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Job DescriptionSalary: $33-35/hour Summary The Sr. Quality Control Specialist works under the general direction of Head of Quality as the lead for Quality Control laboratory. The primary responsibilities are: timely disposition of Raw Materials, In-Process and Customer Supplied Bulks and efficient operation of Quality Control laboratory. Hours would be : 2pm to 10:30pm M-F onsite. Essential Responsibilities Help Develop, implement and maintain QC systems and measures • Inspect and test Raw Materials, Fragrances, In-Process and Customer supplied bulk, against specification to ensure quality standards are met., • Establish priorities to ensure timely job completion., • Issue adjustments to In-Process Bulk if necessary, • Complete Inspections forms for Finished Bulk/Intermediate and /or Raw Materials and Fragrances., • Update status of Raw Materials and /or Bulk/Intermediate in ERP system, • Communicate quality control information to all relevant organizational departments, outside vendors or contractors, • Produce and communicate reports regarding nonconformance of products, • Assist in investigations related to Nonconformance or OOS, Customer Complaint, • Provide Department related data, trends etc. for Management Review, • Resolve production and manufacturing problems to minimize cost and delay, • Maintain the raw material retains for the Department, • Maintain all Quality Systems logs related to the Department, • Monitor Performance of QC systems to ensure effectiveness, efficiency and compliance to company SOPs and regulatory requirements, • Assist in updating or writing Department related SOPs and Work Instructions or other Department related documents., • Review statistical studies, technological advances or regulatory standards and trends to stay abreast of issues in the field of quality control, • Identify and implement training needs for the production team to meet quality standards, • Instruct staff in QC and analytical procedures, • Assist in Raw Materials and Bulk /Intermediate Cycle Counts and Full Inventories, • Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff and vendors and outside agencies Qualifications To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions • Discretion in handling confidential and sensitive matters, • Bachelors degree in science (chemistry, pharmacy, or biology) or equivalent work experience., • Proficient use of Microsoft Office products including Word, Excel, Outlook and PowerPoint., • Experience using common laboratory equipment such as pH Meter; Refractive Index; Pycnometer; Brookfield Viscometer; Color Matching; Scales; and lab mixers, • Must be able to clearly and concisely communicate verbally and in writing in English, • Ability to speak and understand Spanish is a plus, • Must be able to analyze and present quantitative data. Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise including: • Resolve issues of a general, routine and complex nature and exercise appropriate judgment to escalate issues to senior management., • Effectively prioritize routine and non-routine work assignments to ensure goals and timelines are met. The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. • Must have good visual/organoleptic alertness., • Must be able to sit for up to eight hours per day, lift and carry up to 20 lbs with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor level cabinet or drawer; push and pull, use a computer keyboard throughout the workday, stand while filing or performing other essential responsibilities., • Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or white out. Additionally, the incumbent will be exposed to chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs., • Must have reliable transportation and valid drivers license and be able to drive to appointments. Must maintain current, in-force vehicle insurance. Local candidates only. No Recruiters please.

Job DescriptionOverview We are seeking a detail-oriented and experienced Quality Assurance Inspector to join our team. This role is essential in ensuring that all products meet strict quality standards and industry regulations. The ideal candidate will have a strong background in inspection practices, quality audits, and regulatory compliance, particularly within aerospace and medical device manufacturing. Key Responsibilities * Perform thorough inspections of components and finished products using precision measuring instruments such as calipers and coordinate measuring machines (CMM). * Use vision inspection systems to evaluate product quality and detect defects. * Conduct quality audits in alignment with ISO 13485 standards and FDA regulatory requirements. * Collaborate with production teams to ensure parts and assemblies meet specified quality standards. * Document inspection outcomes, report non-conformances, and recommend corrective actions. * Maintain accurate and organized records of inspections and audits for traceability and compliance. * Assist in developing, implementing, and improving quality assurance procedures and protocols. Qualifications & Experience * Minimum of 3 years' experience in QA/QC within aerospace or medical device manufacturing (required). * Strong knowledge of ISO 13485 and FDA regulations (highly desirable). * Skilled in the use of precision measuring tools, including calipers. * Familiarity with vision inspection systems and internal quality audits is a plus. * Excellent attention to detail with strong analytical and problem-solving abilities. * Effective communication skills and ability to collaborate across teams. Benefits * 401(k) with company matching * Health insurance coverage • Paid Time Off/Vacation Time

Job DescriptionBenefits: • 401(k), • Competitive salary, • Opportunity for advancement Position Overview We are seeking a detail-oriented Unblinded Vaccine Coordinator to join our clinical research team. In this critical role, you will manage all unblinded study drug activities for vaccine clinical trials, including receipt, preparation, accountability, and documentation. You will work closely with the principal investigator, research nurses, and study staff to ensure accuracy and compliance while maintaining the integrity of the blind. Key Responsibilities • Maintain study drug accountability logs and documentation in compliance with protocol and regulatory requirements., • Prepare, dispense, and/or oversee vaccine administration per protocol., • Coordinate with the study team while preserving the blind for blinded personnel., • Monitor vaccine storage conditions, including temperature logs and chain of custody., • Train and educate staff on unblinded procedures as required., • Communicate with sponsors, CROs, and monitors regarding investigational product management., • Ensure adherence to ICH-GCP, FDA regulations, and site SOPs.

Job Description Quality Specialist - Plastics - Base Salary to 80k/year - Commerce, CA • Our client is an innovative manufacturer of plastic films used in the Graphics, Signage, and Labeling industry. They are among the top performers in the industry!, • Receives drawings and/or specifications from customer and transfers to the company specification process, • Manages spec review meetings to assure specifications are implemented in a timely fashion, • Interfaces with customer and obtains specification approval as appropriate, • Updates QAD as appropriate for initiation or change to specification, Bill-of-materials, wind ups, and blender sheets, • Participates in customer complaint process as appropriate, • Facilitates coordination of new formats to all manufacturing/quality documents, • Manages electronic document management system (EQMS), • Identifies basic quality issues as related to document structure, format or change control, • Review Vision System output data for final disposition., • Participates in internal audits as assigned., • Participates in Customer audits, • Participates in annual cost roll-up activities in QAD for each active item number (coordinated by Finance), • Minimum requirement of Associates degree (required), • Excellent verbal and written communication skills., • Experienced in an ISO or FDA regulated industry., • Previous internal audit experience or training helpful, • Familiarity in regulatory compliance regarding medical formulations and medical devices., • Familiarity with Quality Systems and all procedures relative to the position., • Base salary up to 80k/year, • Benefits: 100% EE only, starts 1st of the month after start date, • 401k plan - 5% match after #INDVIS

Job DescriptionVolt is immediately hiring Quality Control Associate in Chatsworth, CA! Volt takes great care of our great hires! As a Quality Control Associate you will: • Strong understanding of quality control principles, standards, and testing methodologies., • Experience with analytical tools, equipment, and data management systems., • Conduct laboratory tests on raw materials, in-process samples, and finished cosmetic products to verify they meet established quality and safety specifications., • Perform final product audits and quality checks, confirming adherence to all production and quality standards before release., • Inspect incoming raw materials to ensure they meet quality standards and assess supplier quality. This is a Full-Time 1st Shift Opportunity. 7:30am- 4pm Pay Rate: $25-32/hr The ideal candidate will have: • 7+ years with proven experience in quality control, preferably within the cosmetics or chemical manufacturing industries., • Familiarity with GMP, FDA, and other relevant regulatory standards for cosmetics., • Microsoft Office (Word, Excel, Outlook)*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please call (866) -898-0005. Please indicate the specifics of the assistance needed. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Job Description Job Summary We are seeking a Quality Assurance Specialist to ensure our products and operations comply with all applicable U.S. federal, state, and local regulations. This role will play a critical part in bridging communication with our Korea HQ, overseeing product compliance, import documentation, product quality-related customer claims (VOC), and regulatory audits. You will be a key contributor in maintaining operational excellence in a fast-growing beauty retail environment. What Youll Do • Review and approve product documentation for store onboarding, including ingredient lists and label compliance in accordance with U.S. regulations., • Evaluate claims, marketing materials, and packaging to ensure regulatory accuracy., • Manage and investigate product quality-related customer claims (VOC), and lead response efforts for product recalls or regulatory inquiries (e.g., FDA, state agencies)., • Ensure compliance of physical retail operations with local legal and regulatory standards., • Provide training and guidance to store staff on compliance-related matters., • Manage import documentation and respond to customs-related issues to ensure smooth clearance and delivery., • Maintain regular communication with our Korea HQ regarding product specifications, documentation, and compliance updates., • Establish, maintain, and enhance compliance policies in accordance with U.S. federal and state regulatory requirements., • Monitor changes in product regulations (e.g., MoCRA, FD&C Act) and proactively recommend necessary updates., • Review supplier audit documentation and conduct on-site inspections when necessary to ensure manufacturing practices meet quality and regulatory standards. Qualifications • 5-10 years of experience in quality assurance, preferably in a U.S.-based beauty or personal care platform, • Bachelors degree or higher in a relevant field (e.g., Chemistry, Biotechnology, Life Sciences), • In-depth understanding of U.S. and international regulatory frameworks (FDA, ISO standards, etc.), • Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements Preferred Qualifications • Experience working in quality assurance roles at major U.S. beauty retailers or platforms, • Bilingual in English and Korean, • Experience with ISO 22716 certification or compliance (GMP for cosmetics), • Familiarity with cross-border operations and global supply chain regulatory challenges

Job Description About Samyang America Samyang America stands as the #1 Gen Z brand, boldly shaping the future of food culture with innovative flavors, viral trends, and unforgettable brand experiences. We don’t just create food - we craft moments that spark excitement, inspire connection, and celebrate bold individuality. Our mission is to bring daring, delicious products to the market that resonate deeply with the next generation of food lovers. From iconic spicy noodles to creative new launches, we are driven by passion, creativity, and a commitment to pushing the boundaries of taste and culture. At Samyang America, you’ll join a dynamic team that thrives on innovation, collaboration, and a shared love for bold flavor experiences. We value fresh ideas, energetic spirit, and the courage to lead trends rather than follow them. If you’re ready to be part of a brand that’s more than just food - a brand that moves culture and creates unforgettable moments - join our team today! Responsibilities: * Manage and interpret food regulations for the U.S., Canada, Mexico, and Latin American countries * Continuously track updates in international food regulations and communicate key changes to internal stakeholders * Develop and maintain compliant product labels in accordance with country-specific regulatory requirements, while also incorporating brand-specific characteristics into labeling to ensure alignment with product identity and positioning * Collaborate closely with R&D to ensure regulatory alignment, while also working cross-functionally with Marketing and Sales to align labeling and product positioning with strategic goals * Act as a key liaison with food safety and quality assurance teams at major retail partners to ensure compliance and address product-related inquiries * Work closely with the Sales team to manage manufacturer, product, and warehouse registrations for both mainstream and ethnic retail accounts, while supporting product quality and food safety documentation and issue resolution * Manage documentation and compliance for food safety systems such as FSVP and other country-specific programs * Oversee all export requirements, including customs clearance and product registration with relevant food authorities * Oversee the maintenance and renewal of import permits and certificates to ensure compliance with food safety and import regulations * Manage country-specific tariff classifications and coordinate with SCM to ensure smooth customs clearance and documentation * Analyze and manage customer VOCs to support quality improvement and cross-functional communication * Demonstrate strong data management and documentation skills using Excel, PowerPoint, and internal systems Qualifications: * At least 2 years of work experience with food, cosmetics, pharmaceutical or manufacturing field preferred * Knowledge of the regulations of FDA/USDA and custom matter * Basic understanding of GMP and food production fundamentals * Strong communication skills * FSVP * Computer literacy (Excel, Word etc.) * Bilingual (English/Korean) preferred The base salary for this position is between $55,000.00 and $70,000.00 per year. Actual compensation will depend on a variety of factors, including qualifications, experience, and location. This position may also be eligible for additional compensation and benefits, including an annual incentive bonus, medical/dental/vision insurance, life insurance, PTO/FTO, and a 401(k) plan with company match. Equal Employment Opportunity Employer: Samyang America is committed to providing equal employment opportunities to all individuals. We do not discriminate in employment decisions on the basis of race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by applicable federal, state, or local laws.

Job Description The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Job Summary: The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for TriMed products globally. Supervisory Responsibilities: None. Duties/Responsibilities: • Perform gap analyses between new/revised regulations and standards and the TriMed Quality Management System (QMS)., • Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance., • Compile Clinical Evaluation Plans and Reports., • Assess reportability of changes to: labeling, design, materials, manufacturing process, sterilization or packaging., • Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc., • Compile needed post-market reports., • Facilitate the completion of actions identified as a result of post-market reports., • Compile necessary documentation for the creation of technical files. Maintain technical files., • Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies., • Develop responses to questions or deficiency letters from regulatory agencies and notified bodies., • Use technical/clinical writing skills to clearly describe technical information for third party reviewers., • Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.)., • Maintain registrations, certifications, and/or licenses, as applicable., • Assist new product development teams to provide regulatory support to the project, • Develop positive working relationships with other departments., • Actively participate in third party audits of TriMed. Required Skills/Abilities: • Experience with US and international regulations, and regulatory submissions preferred., • Experience in writing/maintaining CE Technical Files preferred, • Experience in international medical device licensing preferred, • Excellent written and verbal communication skills, analytical skills and sound interpersonal skills, • Strong attention to detail and pride in accuracy, • Excellent proficiency in Microsoft Office (Word, Excel, Outlook, Power point), • Exceptional organizing and prioritizing skills, • Ability to manage and track progress of project deliverables in order to meet deadlines and budgets, • Ability to influence people and functions, • A team player with positive can-do attitude, • A self-motivated and energetic person with an ability to work well under pressure Education and Experience: • Bachelor’s degree preferred., • Two years of medical device, pharmaceutical, or other FDA-regulated industry experience required. Physical Requirements: • Ability and initiative to work in the following environments: ambiguous, fast paced, hands-on, and deadline dictated, • This position works in an open office environment or position can be performed remotely., • While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit. TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Job Description POSITION SUMMARY The Occupational Health & Safety Manager is responsible for providing a safe and healthful atmosphere within the workplace and for compliance with all federal, state and local environmental and safety regulations for the company. He/she is responsible for providing support to the local site, as well as out-of-state facilities; inspecting the facilities to identify safety, health, and environmental risks; developing health and safety procedures for all areas of the company; preparing and scheduling training to cover emergency procedures, workplace safety, and other relevant topics, as well as monitoring compliance with safety procedures. ESSENTIAL FUNCTIONS Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Develop, implement and manage the occupational health & safety programs, policies and procedures for the company., • Serve as facility representative to regulatory agencies, • Administer OSHA logs, documents, inspections and audit records, • Maintain the Illness, Injury and Prevention Program (IIPP), • Maintain hazardous waste and universal waste programs related records, MSDS, manifests and associated files, • Develop, secure or provide safety orientation and training (safety, accident prevention, investigation)., • Provide safety orientation for new hires (employees, leased workers, temporary staff), • Develop and conduct effective EH&S training for production, warehouse, laboratory and office environments (includes all levels of employees). Conduct monthly safety training in necessary or required topics, • Review and update training modules to ensure regulatory compliance, • Certify equipment operators on forklifts, aerial lift platforms, fall protection, confined spaces, • Conduct audits, inspections, investigations, studies and report appropriately to the relevant function heads and managers., • Conduct EH&S audits and implement appropriate changes to correct or comply with regulations, standards and company policy, • Perform daily safety inspections and audits of the facilities and staff: exit doors, fire extinguishers, building lights, first aid stations, PPE, job assessments, machinery and safety equipment to identify and correct potential hazards, • Conduct investigation (RCA) for injuries, accidents and near hits to develop strategies to eliminate root cause or to minimize hazards, • Conduct the Self-Assessment checklist (FDA) for all facilities and report findings and recommendations to TS, • Coordinate industrial hygiene studies as needed (hearing test, noise, gas monitoring), • Coordinate Lab Safety, Locker inspection, Parking lot inspection and Food Defense programs and plant security, • Communicate on internal and external EH&S changes, trends and best practices to reduce risks and improve safety., • Track safety performance at the facilities and report regularly (monthly safety meetings), • Use established channels (e.g. databases, journals etc.) to monitor changes in the regulatory environment (e.g. OSHA, DOT, EPA etc.) as related to EH&S and food manufacturing, • Provide recommendations and provide support for changes to internal policies and procedures necessitated by new regulations or our internal safety performance • Problem Solving, • Drive for Results, • Managing & Measuring Work, • Building Effective Teams, • Motivating Others SUPERVISORY RESPONSIBILITIES This position has no supervisory responsibilities. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. REQUIRED EDUCATION, SKILLS and EXPERIENCE • A minimum of a Bachelor’s degree in Environmental Health & Safety, Safety Management or equivalent is required., • 7+ years of hands-on EHS management experience in manufacturing environment (preferably in food manufacturing industry)., • Strong working knowledge of Cal-OSHA and Federal OSHA regulations is required., • Proven successful records in driving safety vision change and culture shift modeling., • Safety certification is a plus e.g. Certified Safety Professionals (CSP)., • Strong administrative, recordkeeping, regulatory information, and follow-up skills are required., • Ability to work evening shifts and weekends as needed., • Ability to understand, promote, support and drive for safety vision change and culture shift modeling., • Ability to interpret and be the main point of contact for OSHA and other federal/state regulation related responsibilities., • Ability to lead and/or facilitate team meetings such as Safety Committee meetings., • Ability to work in a fast-paced manufacturing environment., • Must have a strong sense of ownership and accountability., • Good multi-tasking, organizational and time management skills., • Working knowledge of Microsoft Office (Outlook, Word, Excel and PowerPoint)., • Knowledge of warehouse and manufacturing equipment operation., • Ability to maintain high proficiency while working in a non-climate-controlled environment., • Must have a valid driver’s license to perform essential functions. LANGUAGE SKILLS • This individual must possess excellent and effective communication and presentation skills, both written and verbal, to employees, leaders and Headquarters in Hong Kong., • Bilingual in English & Chinese or English & Spanish is highly preferred. MATHEMATICAL SKILLS • This Individual must be able to apply basic mathematical concepts to perform daily functions. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • Regularly required to use hands and fingers to perform daily job functions., • Required to stand, sit, kneel, and walk when performing essential job functions., • Occasional lifting and/or moving up to 50 pounds. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. • The noise level in the work environment is light to moderate., • The individual will conduct most work in an office or conference room setting., • The position must become familiar with the work performed at the company; occasional visits to the manufacturing plant are expected., • The position requires occasional travel. IIt is Lee Kum Kee’s policy to seek and employ the most qualified persons in all jobs in a manner which will ensure equal employment opportunity as well as administer personnel actions in a manner as to not discriminate against any person on the basis of race, color, religion, national origin, age, sex, sexual orientation, disability or protected veteran status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Description Overview The Senior Engineer I - Mechatronics provides advanced technical leadership and strategic guidance to multi-functional teams in design and development of complex trauma medical device systems and subsystems. The Senior Engineer leads all aspects of the device development process and lifecycle, including technology roadmap planning, advanced system architecture design, cross-functional team leadership, and mentoring of junior engineering staff. This includes managing complex projects, leading cost benefit analysis and optimization initiatives, advanced prototyping and testing methodologies, and driving innovation from early concept through design refinement, process development, and post-market activities. This position involves advanced tasks such as system-level electro-mechanical design, control architecture development, advanced simulation and modeling, comprehensive test strategy development and data analysis; utilizing advanced CAD, simulation, and statistical analysis software to create, optimize, and validate complex designs. This position requires hands-on leadership in advanced prototyping and process development, qualification of complex equipment and systems, verification and validation strategy development and execution. Leading cross-functional laboratory teams, maintenance of Design History Files and Quality System documentation, and leadership in Risk Assessment and Risk Management processes across multiple projects. This job is well suited to experienced professionals who can lead and contribute to innovation teams, conceptualize, architect and build complex mechatronic systems for trauma medical devices, and drive strategic technology decisions. This individual is able to work independently, provide effective program management across multiple projects, and mentor junior engineering staff. This person should have deep expertise and leadership experience in research and development, design, test, and manufacturing in mechanical, electrical, and software engineering fields. This individual should also demonstrate excellent leadership, communication, technical writing, strategic thinking, and program management skills. This is an on-site, full-time position. The Senior Engineer - Mechatronics will provide strategic technical leadership and support to device development activities as assigned at the discretion of management. Reports to: VP of Production & Engineering Duties and Responsibilities: The Senior Engineer I - Mechatronics responsibilities typically involve: • Lead and architect the development of complex electro-mechanical systems, automated control platforms, and integrated medical device ecosystems to support advanced trauma care applications, manufacturing optimization, and next-generation packaging processes., • Lead and contribute to cross-functional teams in advanced lab and bench-top testing programs. Architect, build, and validate complex mechatronic system designs through advanced CAD modeling, multi-physics simulation, and sophisticated prototyping methodologies, perform comprehensive system evaluations, and lead completion of device design to facilitate seamless transfer to manufacturing (Good Manufacturing Practices)., • Lead strategic coordination across engineering disciplines to analyze and perform comprehensive assessment of mechatronic systems for verification and validation activities. Architect and lead the coordination of complex device and product testing programs, develop advanced technical protocols (Good Document Practices) and comprehensive reports, including statistical data analysis and advanced control system performance optimization., • Drive innovation and ideate breakthrough concepts to develop next-generation mechatronic components, subassemblies and control technologies for advanced functionality across all trauma device development programs., • Lead design and implementation of advanced PLC programming, sophisticated HMI interfaces, complex embedded control systems, and robotic automation platforms for critical medical device applications., • Conduct advanced FEA, CFD, and multi-physics system simulation for novel mechatronic components and integrated systems, including functional safety analysis., • Lead development of comprehensive engineering documentation including production drawings, electrical schematics, control system architecture, and advanced system integration documentation., • Drive collaborative development of innovative production techniques and advanced manufacturing processes across all stages of complex mechatronic device development., • Lead maintenance of project documentation across multiple programs, including Standard Operating Procedures, Design Control Documentation, Design History Files, Quality System Documentation, and Risk Management Documents in compliance with FDA regulations and ISO standards., • Mentor and provide technical leadership to junior engineering staff, including recruitment, training, and professional development activities., • Represent the company at technical conferences, workshops, and industry events to maintain awareness of emerging technologies and establish strategic partnerships., • Lead technology roadmap development and strategic planning for mechatronic systems and platform development. The Senior Engineer I - Mechatronics should be able to utilize and lead development of advanced skills and experience to drive innovative solutions for complex integrated electro-mechanical systems; lead selection and application of advanced test equipment and methodologies and resolve complex technical challenges that arise during performance of duties and responsibilities. The following abilities may aid the Senior Engineer - Mechatronics in completion of these tasks: • Expert proficiency with advanced CAD (SolidWorks, CATIA) and simulation software (MATLAB/Simulink, ANSYS Workbench) for creating, optimizing, and validating complex mechatronic systems and components., • Expert proficiency in multiple programming languages including Python, C/C++, LabVIEW, and MATLAB for advanced control system development, data analytics, and system integration., • Expert proficiency in PCB design, complex embedded systems, sensor fusion, advanced actuators, robotic control algorithms, and sophisticated electronic system integration., • Advanced proficiency in PLC programming, HMI development, SCADA systems, and complex industrial automation architectures., • Advanced proficiency in advanced simulation techniques (multi-physics FEA, CFD, controls modeling) and system optimization methodologies., • Ability to apply advanced mechanical, electrical, control theory, and systems engineering principles to architect and optimize complex designs and models., • Expert experience with advanced metrology equipment, automated test systems, and comprehensive system validation methodologies., • Deep knowledge of medical device manufacturing techniques, regulatory requirements (FDA 21 CFR Part 820, ISO 13485, IEC 62304), and functional safety standards., • Comprehensive knowledge of biocompatibility requirements, sterilization processes, and advanced packaging solutions for medical devices., • Advanced problem-solving and leadership abilities to resolve complex technical challenges and lead cross-functional teams through difficult development programs., • Strong technical leadership and mentoring skills to develop junior engineering talent and drive team performance., • Exceptional math and advanced engineering skills to perform complex calculations, statistical analysis, and system optimization., • Self-motivated with strong program management skills to ensure completion of multiple complex projects within demanding timelines., • Highly organized with exceptional attention to detail required for regulated medical device development across multiple product lines., • Excellent leadership and communication skills for cross-functional collaboration with clinical, regulatory, and executive teams., • Proven ability to lead and inspire cross-functional collaborative teams in fast-paced development environments., • Advanced proficiency with Microsoft Office Suite, project management software (MS Project, JIRA), and data analysis tools., • Bachelors or Master's Degree in Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, or related field., • 5-7 years experience in mechatronic system design and development, with significant experience in medical device or highly regulated industry, including robotic system development and deployment., • 5-7 years demonstrated success in complex control system programming, robotic system integration, and automation implementation., • Extensive experience with medical device regulatory processes, FDA Design Controls, and regulatory submissions., • Advanced experience with tolerance stack-up analysis software (e.g. Cetol) and statistical process control., • Deep knowledge of wireless communications, IoT applications, and connectivity solutions in medical devices., • Extensive experience with robotic systems, surgical automation platforms, medical robotics, or advanced medical device systems., • Professional Engineer (PE) license., • Published technical papers or patents in mechatronics or medical device fields. To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Benefits: • 401(k) Safe Harbor Plan, • Healthcare Insurance: Medical, Dental and Vision, • Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance, • Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave, • Tuition Reimbursement Program, • Performance Bonus, • Flexible Schedule Salary $100,000 - $140,000 per year Privacy Policy | Critical Innovations

Job DescriptionWe are seeking an Environmental Monitoring Technician to join our team in Duarte, CA! This position starts as an initial 12-month contract with the likeliness of an extension or a direct offer. The Environmental Monitoring Technician I will independently perform tasks related to environmental monitoring to support the regulatory requirements of cell and gene therapy facilities. This position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting. Schedule: Monday-Friday, days. Pay rate: $33.00/hour Essential Duties: • Operate various equipment in GMP facilities supporting GMP operations., • Prepare documentation of activities, actions, and results Ensure proper documentation practices during job activities, • Read and execute SOPs (Standard Operating Procedures), • Maintain accurate and complete records (for example - laboratory notebooks, quality records, sample receipts), • Complete required training Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions, • Coordinate activities of support groups Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions, • Perform routine sampling activities and associated data entry, • Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities, • Read and interpret diagrams, drawings, and other schematics, • Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance, • Provide feedback on service and quality issues on a timely basis Qualifications:, • Bachelors Degree in Life Sciences (preferred), • Must have the ability to effectively understand, read, write, communicate, and follow instructions in English, • Good attention to detail is required., • Must be capable of keeping accurate records and performing mathematical calculations., • One to two years of experience in a pharmaceutical production environment. #IND1

Job Description Production Group Leader/ Supervisor Location: Garden Glove, CA Pay: $27.00 - $29.00 per hour+Benefits (Insurance, PTO etc) Job Type: Full-time 8 to 10 hour shift (Monday to Friday) Expected hours: 40 – 50 per week Overtime, Weekends as needed High school or equivalent (Required) Production Supervisor: 3 years (Required) English and Spanish (Required) Onsite Key Responsibilities: ・Supervise and coordinate daily activities of production associates ・Train, coach, and evaluate production staff; conduct performance reviews and disciplinary actions ・Ensure accurate completion of production records, inventory logs, and downtime reports ・Collaborate with quality assurance team to minimize production disruptions ・Monitor equipment performance and coordinate preventive maintenance with the mechanics ・Enforce safety procedures, GMP, HACCP, and other regulatory compliance policies ・Participate in continuous improvement initiatives to optimize efficiency, reduce waste, and improve product consistency ・Report operational issues and improvement suggestions to senior management Qualifications: ・High school diploma or equivalent required; Associate’s or Bachelor’s degree in Food Science, Engineering, or related field preferred ・Min 3 years of supervisory experience in food manufacturing or a related production environment ・Strong understanding of food safety standards (FDA, HACCP, GMP) ・Effective leadership, problem-solving, and communication skills ・Ability to read and interpret production metrics, technical documents, and reports ・Proficient in Microsoft Office ・Ability to work in a fast-paced environment and manage multiple priorities Work Environment: Manufacturing plant environment with exposure to heat, noise, and food processing equipment Must be able to stand, walk, bend, and lift for extended periods May be required to work weekends, holidays, or overtime as needed Company DescriptionWe are a Talent Acquisition/People Operation (HR) group that connects people to careers and professional growth. Would you like to look for a new job opening to expand your career path or a new applicant for your opening position? Then you are in the right place to start! TOP Group has grown from a single office in New York in 1992, to one of the global leaders in Japanese-related talent solutions today. As one of the first Japanese staffing agencies in the U.S., we started our focus in Finance but quickly expanded to other industries such as Technology, Freight Forwarding, Trading, and Manufacturing. We have offices in New York - Head Quarters, San Francisco, Los Angeles, and Houston. We have been expanding to Mexico to assist the Japanese corporations and become the #1 Japanese Recruiting Agency in Central America. Our Industries include: ●\tIT/Innovation ●\tManufacturing ●\tTrading ●\tLogistics ●\tEngineering ●\tOil & Gas ●\tCPA/Accounting ●\tFinance/Bank ●\tEntertainment If you are open to new job opportunities or interested in developing your career path, please follow our page, and let’s connect! You are more than welcome to InMail recruiters below. Unsure of which office to connect to? No worries! We will direct you to the nearest office for your desired location. For more information, please visit our website. are a Talent Acquisition/People Operation (HR) group that connects people to careers and professional growth. Would you like to look for a new job opening to expand your career path or a new applicant for your opening position? Then you are in the right place to start!\r\n\r\nTOP Group has grown from a single office in New York in 1992, to one of the global leaders in Japanese-related talent solutions today. \r\n\r\nAs one of the first Japanese staffing agencies in the U.S., we started our focus in Finance but quickly expanded to other industries such as Technology, Freight Forwarding, Trading, and Manufacturing. \r\n\r\nWe have offices in New York - Head Quarters, San Francisco, Los Angeles, and Houston. \r\n\r\nWe have been expanding to Mexico to assist the Japanese corporations and become the #1 Japanese Recruiting Agency in Central America.\r\n\r\nOur Industries include:\r\n●\tIT/Innovation\r\n●\tManufacturing\r\n●\tTrading \r\n●\tLogistics\r\n●\tEngineering \r\n●\tOil & Gas\r\n●\tCPA/Accounting \r\n●\tFinance/Bank\r\n●\tEntertainment\r\n\r\nIf you are open to new job opportunities or interested in developing your career path, please follow our page, and let’s connect! You are more than welcome to InMail recruiters below. Unsure of which office to connect to? No worries! We will direct you to the nearest office for your desired location.\r\n\r\nFor more information, please visit our website.

Job Description Job Title QFS Compliance Specialist Location City of Industry, CA – Manufacturing Facility (onsite) Employment Type/Salary Full-time W2 Contract (Estimated 6 months- could extend or potentially lead to full time role) Day Shift- $45/hr (anything over 40 hours or over 8 hours in a day is OT) Healthcare, Dental, Vision, Disability, Life Insurance offered and eligible to sign up after 30 days. Job Purpose As a high-visibility member of the Food Safety & Quality team, you’ll manage and coordinate all quality-compliance activities across our manufacturing site. You’ll own audit-ready processes for food safety and regulatory programs—including FSSC 22000, FSMA, Non-GMO, Organic, Kosher and related standards—and help the team maintain 100% compliance. Essential Responsibilities • Program Ownership: Maintain and review all food-safety and regulatory compliance records (CCPs, OPRPs, PCs), such as processor, sterile-tank and filler charts, CIP logs, raw-receiving and sugar-tank records., • Deviation Management: Escalate and drive corrective-action plans for any process deviations or non-conformances., • Root-Cause Investigations: Lead cross-functional problem-solving teams to close out issues and prevent recurrence., • Audit Support: Prepare for and support internal, regulatory and customer audits; coordinate CAPA close-out., • Regulatory Compliance: Ensure HACCP/FSHCP, FSMA, GMP, Non-GMO, Organic and Kosher activities are performed and documented properly., • Complaint Handling: Lead consumer- or customer-complaint investigations from root-cause through resolution., • Equipment Calibration: Verify equipment calibration and maintenance schedules; maintain calibration records., • Transition Management: Oversee product and packaging line changeovers to guarantee compliance and documentation., • Program Administration: Support complaint-management, pest-control and traceability initiatives., • Document Control: Administer and update controlled procedures, work instructions and training materials., • Training Delivery: Develop and deliver food-safety and quality training; keep materials current., • Continuous Improvement: Identify and implement process improvements to bolster safety and quality systems., • Backup Support: Serve as backup to the QFS Compliance Supervisor as needed. Education & Experience • BS/BA in Food Science, Technical Field or equivalent experience, • 3–5 years in food- or ingredient-manufacturing compliance roles, • PCQI certification, • Federal & state regulatory requirements (FSMA, GMP, etc.), • Familiarity with Non-GMO, Organic and Kosher processes, • Strong document-control and record-keeping abilities, • Excellent communication, presentation and organizational skills, • Proficient in Microsoft Office; experience with SAP or similar systems preferred, • Demonstrated experience developing, implementing, and maintaining Food Safety Plans in compliance with FSMA requirements., • Hands-on involvement with Food Defense programs, Vulnerability Assessments, and mitigation strategies., • Familiarity with supplier verification, allergen control, sanitation controls, pest control, traceability, and recall programs., • PCQI (Preventive Controls Qualified Individual) certification., • HACCP Certification (International HACCP Alliance)., • Internal Auditor certification for a GFSI-recognized scheme (FSSC 22000, SQF, or BRCGS)., • FSPCA Foreign Supplier Verification Program (FSVP) certification., • Allergen Management or Sanitation certification (e.g., AIB, NSF, or equivalent). Physical & Environmental Demands • Prolonged standing, sitting, bending, stooping and climbing, • Manual dexterity for operating lab equipment, computer keyboards and tools, • Normal hearing and vision (including color perception) for record review and reporting, • Ability to lift up to 50 lbs and work around production machinery, chemicals and solvents, • Adaptability to a fast-paced, pressurized environment with potentially variable shifts

Job DescriptionThe Pack Labs is leading the way in the hemp-derived cannabinoid industry with premium brands like Delta Munchies and Imperial Extraction. With a focus on quality, innovation, and expanding our national presence, we’re committed to creating the highest-quality products that stand out in the market. As we continue to grow, we are seeking a Head of Compliance to lead our regulatory strategy and operations at our new Santa Fe Springs facility. This role is essential to ensuring that our manufacturing processes, product development, and commercial operations remain fully aligned with California hemp laws, FDA and CDPH requirements, and emerging federal and state regulations. The Head of Compliance will report directly to executive leadership and work cross-functionally with operations, quality assurance, legal, and marketing to build and sustain a best-in-class compliance program. This is a hands-on leadership role that combines regulatory knowledge, policy development, internal auditing, and team training into one cohesive, scalable system. Role & Responsibilities • Manage the full lifecycle of business-critical licenses and permits, including hemp extract registration, food processing facility permits, and all related renewals. Prepare supporting documentation for new license applications or modifications based on operational expansion., • Oversee all regulatory compliance efforts across the organization, with a primary focus on California Department of Public Health (CDPH), FDA (for ingestibles), Cal/OSHA, and local health regulations. Monitor and interpret relevant state and federal laws, including HSC §11018.5 and §111920, and provide actionable updates to executive leadership, • Develop and maintain robust Standard Operating Procedures (SOPs) for all regulated processes, ensuring full alignment with cGMP, HACCP, QMS standards, and evolving compliance frameworks. SOPs should clearly govern all manufacturing activities across prerolls, vape filling, and edible production., • Lead the creation of documentation systems that ensure accurate, audit-ready records for all regulatory touchpoints, including batch tracking, raw material COAs, sanitation logs, employee training files, and incident or recall reports., • Establish and execute internal audit schedules to assess compliance adherence across departments. Identify risk, lead root cause analysis, and implement corrective and preventive actions (CAPA) as needed., • Oversee compliance testing protocols for all raw materials and finished products. Confirm results meet required thresholds for potency, contaminants, and microbial content. Review all packaging and labels to ensure compliance with California and FDA regulations, including ingredient panels, QR codes, and health warnings., • Serve as the primary point of contact for state and federal inspections. Lead the organization’s audit preparedness and respond to compliance-related notices, product holds, or consumer complaints in collaboration with legal counsel when necessary., • Design and lead company-wide training initiatives on regulatory expectations, GMP practices, and hygiene protocols. Maintain documentation of all compliance training activities and ensure they are refreshed and up to date., • Support environmentally responsible waste disposal practices and ensure compliance with CalEPA and hazardous materials handling requirements., • Minimum 3 years of compliance leadership experience in a regulated manufacturing environment (cannabis or hemp), • In-depth understanding of California and nationwide hemp regulations, FDA and CDPH standards, and food safety laws, • Strong working knowledge of cGMP, HACCP, QMS, and regulatory audit frameworks, • Proven success developing and enforcing SOPs, maintaining licensing portfolios, and managing regulatory audits and inspections, • Demonstrated ability to build documentation systems that support transparency, traceability, and recall readiness, • Exceptional attention to detail, organizational discipline, and risk management acumen, • Strong communication and leadership skills with the ability to influence and educate across departments and levels of seniority, • Experience collaborating with executive teams and regulatory counsel on compliance strategy and operational impact, • Must be 21+ and authorized to work in the United States What We Offer • Competitive salary: $60,000- $90,000, • Full benefits package including medical, dental, vision, and paid time off, • High-visibility leadership role with significant impact on the company’s growth and operational integrity, • A collaborative, high-performance environment built on accountability, transparency, and innovation THpsGVj0hc

Job Description About Samyang America Samyang America stands as the #1 Gen Z brand, boldly shaping the future of food culture with innovative flavors, viral trends, and unforgettable brand experiences. We don’t just create food - we craft moments that spark excitement, inspire connection, and celebrate bold individuality. Our mission is to bring daring, delicious products to the market that resonate deeply with the next generation of food lovers. From iconic spicy noodles to creative new launches, we are driven by passion, creativity, and a commitment to pushing the boundaries of taste and culture. At Samyang America, you’ll join a dynamic team that thrives on innovation, collaboration, and a shared love for bold flavor experiences. We value fresh ideas, energetic spirit, and the courage to lead trends rather than follow them. If you’re ready to be part of a brand that’s more than just food - a brand that moves culture and creates unforgettable moments - join our team today! Position Summary We are seeking a highly experienced Regulatory Affairs & QA/QC Part Leader to lead regulatory compliance and product quality initiatives across the U.S., Canada, Mexico, and Latin American markets. The ideal candidate will have a strong background in international food regulations, food labeling, import/export compliance, and cross-functional collaboration. This role requires strategic thinking, leadership, and the ability to effectively guide junior team members while engaging with major retail customers and regulatory bodies. Key Responsibilities: * Lead regulatory interpretation and compliance strategy for food products across the U.S., Canada, Mexico, and Latin American countries, ensuring alignment with evolving international regulations. * Oversee and approve product labeling to ensure full compliance with country-specific regulatory requirements while maintaining brand identity and marketing consistency. * Coordinate with external expert groups on regulatory risk assessments, labeling compliance, and legal strategy * Proactively monito regulatory changes and access potential business impact; translate key updates into actionable guidance for internal teams. * Serve as a regulatory and lead in cross-functional teams, collaborating with R&D, Marketing, and Sales to drive successful product launches and continuous improvement. * Act as a key liaison with food safety and quality assurance teams at major mainstream and ethnic partners/channels to ensure compliance and address product-related inquiries * Manage regulatory documentation for product, manufacturer, and warehouse registrations. * Oversee food safety system compliance, including FSVP, GFSI-aligned programs, and relevant country-specific import/export requirements. * Ensure timely maintenance of all import permits, product registrations, and export certificates coordinating with authorities and customs brokers. * Provide strategic oversight on HS code classifications, customs documentation, and collaboration with SCM for logistics operations. * Analyze customer VOCs to support quality improvement and cross-functional communication * Demonstrate strong data management and reporting skills. And lead and mentor junior team members, providing guidance, project oversight, and professional development support. Requirements: * At least 9 years of work experience with food, cosmetics, pharmaceutical or manufacturing field preferred. * Knowledge of the regulations of FDA/USDA and custom matter. * Basic understanding of GMP and food production fundamentals. * Strong communication skills. * FSVP * Computer literacy (Excel, Word etc.) * Bilingual (English/Korean- preferred) The base salary for this position is between $90,000.00 and $115,000.00 per year. Actual compensation will depend on a variety of factors, including qualifications, experience, and location. This position may also be eligible for additional compensation and benefits, including an annual incentive bonus, medical/dental/vision insurance, life insurance, PTO/FTO, and a 401(k) plan with company match. Equal Employment Opportunity Employer: Samyang America is committed to providing equal employment opportunities to all individuals. We do not discriminate in employment decisions on the basis of race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by applicable federal, state, or local laws.

Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Sr. Planner, Facilities to work for a leading Greater Los Angeles area biotechnology company. Pay Range: $35-45/hour depending on experience Responsibilities: • Adhere to Safety and GMP procedures, ensure a safe work environment, • Primary System Administrator for the CMMS, • Input and delete new equipment records into the system, • Process Corrective work orders, • Process Preventive maintenance work orders, • Process Calibration work orders, • Generation of automatic scheduling, • Provide required management and regulatory reports, • Sustain the equipment files and work history files, • Execute the Facilities Change Control Program, • Maintain GMP equipment history, • Maintain parts inventory, • Scheduling and Planning with vendors and contractors, • Meet with department leaders and plan scheduling on PM’s and Cal’s, • Understand storeroom inventories, min/max, and manages parts inventory and prioritize ordering., • Work with production scheduling and provide input on work orders based on maintenance capacity, parts inventory, scheduled projects, and maintenance resources, • Track all PM/CAL/CM Work Orders and follow throughout completion, • Provide Monthly overdue report of work orders, • Ensure all assets are setup with schedules, • Maintain Asset tracking for all equipment locations within BMRAM, • Facilitate regularly occurring meetings with maintenance staff, including maintenance pre- and post-meetings and tracks key metrics associated with work orders, • Overlook asset inventory of non BMRAM items i.e. Scale up items, • Negotiate best rates for service agreements, • Support maintenance department staff and maintain training records, • Monitor and ensure locations are maintained up to standard and make recommendations to improve the appearance and safety of the location., • Leading general office support functions to include noting any office or building deficiencies, fire hazards or other common interior/exterior building problems, • Support drafting and maintaining department SOP’s, • Review and approve orders for office supplies for department use, • Process and track facilities purchasing activities, • Pull data and reports from Blue Mountain RAM system to assist in the development of staff metrics, • Provide clerical support to Facilities and Engineering, • Communicate with our customers to provide updates and clarifications if necessary, • Provide reports to support validation requirements, deviationsRequirements:, • 7+ years of working experience with Computerized Maintenance Management Systems (Blue Mountain preferred but not required), • Bachelor’s degree in related area and/or equivalent experience/training, • GMP facility experience preferred but not required, • 2+ years of experience working in an FDA regulated environment preferred but not required, • Excellent time management and organizational skills required, • A Self-starter and a dedicated team player, committed to providing high-quality support to all organizational levels, • Excellent verbal and written communication skills, • The ability to multitask and exercise good judgment, • The ability to work in a fast-paced environment and maintain a high level of customer service, • Detailed oriented with good follow-up skills, • Proficient in computer usage with standard business software, • Able to travel between different sites, • Proficient in various computer programs like MS Office, • Strong attention to detail, organizational and planning skills, • Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion., • Ability to work in a standing position for long periods of time (up to 8 hours).

Job Description Job Title: Clinical Data Manager – Data Integrity & Analysis Own the data. Shape the science. About RDI RDI is a CRO purpose-built for diagnostics. Since 2008, we’ve completed over 200 trials supporting some of the largest IVD companies in the world. Our mission is to get better tests to market — faster — with cleaner data, smarter tools, and zero nonsense. We work at the intersection of research, tech, and regulatory strategy. If you care about meaningful data, and want to see your work shape real-world decisions, you’ll feel right at home here. The Role We’re looking for a Clinical Data Manager who does more than clean data — you think critically about how it's structured, how it will be analyzed, and whether it will hold up to regulatory scrutiny. You’ll sit between clinical operations and biostatistics, owning the entire flow of subject- and sample-level data. You’ll build eCRFs, validate inputs, spot errors others miss, and help shape how that data is ultimately analyzed and presented. If you’ve ever wanted to be both the person who finds the bad data and the person who can explain why it matters — this is that role. Why This Role? • You’ll have end-to-end ownership: from raw inputs to regulatory-ready datasets, • You’ll work across teams — clinical, lab, tech, and regulatory — with visibility and voice, • Your work won’t just live in spreadsheets. It will show up in FDA filings, strategic meetings, and patient-facing diagnostics Key Responsibilities • Build and optimize electronic case report forms (eCRFs) to simplify physician data entry and reduce protocol deviations, • Review, clean, and validate large clinical datasets (subject metadata, lab results, demographics, etc.), • Flag inconsistencies, errors, and outliers with precision and context, • Format data to support downstream analysis (e.g., standardization, categorical formatting, units, date logic), • Support basic statistical reporting (e.g., inclusion criteria tracking, diversity metrics, confidence intervals, ROC), • Collaborate with our regulatory and science team to ensure final datasets support submission claims, • Partner with Salesforce developers and EDC platforms to improve the usability of our paperless trial systems, • Create reports that help us track site enrollment, sample quality, and trial performance in real time Ready to own the data — and the outcome? Join us and build something that actually matters. Requirements • 3+ years in clinical data management or diagnostics data analysis, • Strong Excel skills, plus familiarity with EDC platforms (Castor, Cloudbyz, REDCap, etc.), • Exposure to basic biostatistics (even if not a statistician): sensitivity/specificity, AUC, stratification, etc., • Ability to write queries, troubleshoot messy data, and explain your logic to both devs and scientists, • A mindset for structure, logic, and accuracy — you question the data before trusting it, • Bonus if you’ve worked with R, SAS, or Python to run analyses or QA data, • Even better if you’ve touched submissions to FDA or worked in regulated diagnostics Ready to own the data — and the outcome? Join us and build something that actually matters. Benefits • Health Care Plan (Medical, Dental & Vision), • Retirement Plan (401k, IRA), • Life Insurance (Basic, Voluntary & AD&D), • Paid Time Off (Vacation, Sick & Public Holidays)

Job DescriptionCompany Description The Wonderful Company is committed to offering high-quality, healthy, and iconic brands such as Wonderful Pistachios, Wonderful Halos, FIJI Water, and POM Wonderful. We’re looking to make the world a healthier place through an uncompromising commitment to the well-being of our employees and their families. We foster a collaborative workforce that encourages an entrepreneurial spirit and openness to change. The Global Regulatory Affairs Specialist plays a vital role in ensuring compliance across the innovation, production, marketing, and sale of food, beverage, wine, and agricultural products worldwide. The Regulatory Team is part of the Wonderful legal team, a full-service law group with approximately 100 individuals that includes real estate, employment, intellectual property, transactional, education, and government affairs teams. This role offers a unique opportunity to be part of a vibrant and entrepreneurial company and work closely with in-house attorneys and partners across The Wonderful Company organization on meaningful projects that directly contribute to our businesses’ success. The Specialist will navigate complex domestic and international regulatory frameworks and help shape regulatory strategy in product development, labeling, advertising, claim substantiation, food safety, and more. We work on sophisticated and novel issues and are looking for someone interested in developing their regulatory expertise with exciting opportunities to grow their career. The Regulatory team is highly regarded across our businesses as go-to thought partners and problem solvers. This position will be based at our West Los Angeles, CA office. We work a hybrid schedule with an in-office requirement Monday-Wednesday and the option to work remotely on Thursday and Friday. Job Description • Interface with our Brand and Innovation Teams on new product development initiatives, particularly as it relates to label claims, product names, nutrition information, and ingredient formulations., • Review product labels (including ingredient statements, nutrition facts, nutrient content claims, health claims, romance copy, and related substantiation) for U.S. (FDA) and international regulatory compliance from concept through final package development., • Assess regulatory requirements for product innovations and entry into new international markets. Coordinate with cross-functional partners to ensure accurate and timely execution., • Interpret and synthesize U.S. and international regulations and guidance documents related to labeling, nutrition, and claims for internal and external partners, with opportunities to deliver presentations and lead discussions on key regulatory topics., • Monitor and track domestic and international regulations, warning letters, enforcement trends, and other developments related to food labeling, nutrition, claims, and food safety., • Research, analyze, and summarize documents published by government agencies to support industry initiatives, comment submissions, and other regulatory strategies., • Review product inquiries and draft responses to customers and regulatory officials., • Maintain and organize substantiation and documentation to support label and product claims., • Develop and maintain compliance tools and resources (e.g., claim trackers, internal reference documents, ingredient spreadsheets, and checklists) by reviewing content and compiling data., • Maintain and update nutrition and ingredient information for U.S. and international products, such as confirming appropriate nutrient calculation methods by country and reviewing ingredient specification details against the relevant rules and regulations., • Collaborate with our Government Affairs Team on reviewing pending legislation and emerging government and health policy issues and their potential impact to the business., • Gain project management experience and support continuous improvement and data management initiatives within the Regulatory team and greater organization, including the development and maintenance of new processes to enhance efficiency, labeling checklists, brand reference guides, and SOPs., • Participate in company-wide initiatives and programs around mentorship, wellness, philanthropy, professional development, and various team and relationship-building opportunities.Qualifications, • 2-5 years' experience in domestic regulatory affairs at a consumer-packaged goods company required., • Bachelor's degree in nutrition, food science or related discipline preferred., • Formal course work or seminars in labeling, claims, and food safety preferred., • Working knowledge of FDA labeling laws and regulations. International regulatory knowledge a plus., • Positive and self-starter attitude with a strong sense of urgency., • Ability to work both independently as well as collaboratively within the Regulatory Team and with cross-functional partners in a high energy environment., • Solutions-oriented team player capable of providing business-minded regulatory advice. Excellent interpersonal and communication skills (verbal and written), including the ability to communicate complex regulatory and scientific issues in simple terms., • Superb organizational skills and high attention to detail., • Demonstrated excellent judgment and common sense., • Strong critical thinking, analytical and problem-solving skills., • Desire to excel and grow within the Regulatory team., • Adaptable to shifting priorities and ability to manage multiple projects with competing deadlines. Additional Information • Thriving Wellness Community: Access to top-notch medical coverage comprehensive vision and dental plans, and a 401k with match eligibility to secure your financial future and including:, • 24/7 online physician consultations, • virtual mental health resources, • life coaching, • engaging employee community groups, • cash rewards for healthy habits and fitness reimbursements, • library of on-demand fitness videos, • Career Advancement Opportunities: Unlock your potential with clear paths for career progression and internal mobility across our diverse family of brands and business units., • Focused Learning and Development: Grow as a leader with our dedicated Learning and Organizational Development department, offering extensive resources like People Manager and leadership training, webinars, and eLearning courses., • Empowering Mentorship Program: Connect with colleagues through our company-wide mentorship program to share goals, overcome challenges, and drive your career forward., • Continuous Improvement Training: Participate in training that empowers all employees to learn and implement concepts that drive significant, positive change in the workplace., • Building a Healthy Society: To date, our co-Founders Lynda and Stewart Resnick, through their foundations and The Wonderful Company, have invested more than $2.5 billion in education, health and wellness, community development, and sustainability initiatives across California’s Central Valley, Fiji, and the world. In 2025, Wonderful ranked as #1 in PEOPLE’s “100 Companies That Care” list and was named one of Fortune magazine’s 100 Best Companies to Work For. To learn more about our corporate social responsibility efforts, visit csr.wonderful.com. The Wonderful Company’s connection to consumers has health at its heart and giving back at its core. The company has a long-standing commitment to corporate social responsibility, including more than $1 billion invested in environmental sustainability; $65 million in charitable giving, education initiatives, and innovative health and wellness programs each year; and $143 million toward the construction of two charter school campuses in California’s Central Valley. To view the current Corporate Social Responsibility report, visit . To learn more about The Wonderful Company, its products and its core values, visit , or follow us on Facebook, Twitter and Instagram. The Wonderful Company is an Equality Opportunity Employer that provides opportunities for advancement. We are committed to creating a diverse workforce that embodies a deep culture of acceptance, equity, and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories. #LI-hybrid EEO is the law - click here for more information

Job DescriptionCompany Description The Wonderful Company is committed to offering high-quality, healthy, and iconic brands such as Wonderful Pistachios, Wonderful Halos, FIJI Water, and POM Wonderful. We’re looking to make the world a healthier place through an uncompromising commitment to the well-being of our employees and their families. We foster a collaborative workforce that encourages an entrepreneurial spirit and openness to change. The Global Regulatory Manager plays a vital role in ensuring compliance across the innovation, production, marketing, and sale of food, beverage, wine, and agricultural products worldwide. The Regulatory Team is part of the Wonderful legal team, a full-service law group with approximately 100 individuals that includes real estate, employment, intellectual property, transactional, education, and government affairs teams. This role offers a unique opportunity to be part of a vibrant and entrepreneurial company and work closely with in-house attorneys and partners across The Wonderful Company organization on meaningful projects that directly contribute to our businesses’ success. The Manager will navigate complex domestic and international regulatory frameworks and help determine regulatory strategy in product development, labeling, advertising, claim substantiation, food safety, and more. We work on sophisticated and novel issues and are looking for someone interested in developing their regulatory expertise with exciting opportunities to grow their career. The Regulatory team is highly regarded across our businesses as go-to problem solvers. This position will be based at our West Los Angeles, CA office. We work a hybrid schedule with an in-office requirement Monday-Wednesday and the option to work remotely on Thursday and Friday. Job Description • Serve as a primary point-of-contact with our Brand and Innovation Teams on new product development initiatives. Assess regulatory requirements and offer business-minded solutions., • Review product labels (including nutrition facts, ingredient statements, front-of-pack (FOP) nutrition, and all claims) and advertising for U.S. and international regulatory compliance. Evaluate substantiation and scientific research, as needed., • Develop and present regulatory trainings to our business partners., • Act as subject matter expert on emerging issues, such as FOP labeling, ultra-processed foods, PFAS, and microplastics. Communicate enforcement trends to Regulatory leadership., • Conduct risk analyses and propose regulatory strategies to Regulatory leadership and cross-functional partners., • Research FDA regulations regarding ingredients, flavorings, food contact substance approvals, GRAS, and more., • Evaluate and respond to compliance requests from B2B customers on Prop 65, PFAS, non-GMO, vegan, etc., • Collaborate with our Government Affairs Team on pending legislation and emerging health policy issues, analyze potential business impacts, and draft comments., • Participate in company-wide initiatives and programs around continuous improvement, automation, mentorship, wellness, philanthropy, professional development, and various team and relationship-building opportunities. Qualifications, • Minimum of 6 years' experience in domestic regulatory affairs within the food and beverage industry. Focus on juice, nuts, bottled water, and produce preferred. Wine experience a plus., • Demonstrated knowledge of FDA labeling laws and regulations, including nutrient content, structure function, and health claims., • Knowledge of Food Safety Modernization Act regulations, global regulatory food law, quality, nutrition, food safety, advertising, and claim substantiation., • Bachelor's degree in nutrition, food science, or related discipline preferred., • Master's degree in food science, food safety, or food law is a plus., • Positive and self-starter attitude with a strong sense of urgency., • Ability to communicate complex regulatory matters in clear, straightforward terms, with confidence in high-stakes settings., • Resilient and adaptable, with the ability to navigate ambiguity and manage pushback effectively., • Strong judgment, analytical thinking, and problem-solving skills., • Demonstrated ability to build strong peer relationships and integrate seamlessly into an entrepreneurial organization., • Excellent interpersonal and communication skills, with the ability to influence and collaborate across teams. Additional Information • Thriving Wellness Community: Access to top-notch medical coverage comprehensive vision and dental plans, and a 401k with match eligibility to secure your financial future and including:, • 24/7 online physician consultations, • virtual mental health resources, • life coaching, • engaging employee community groups, • cash rewards for healthy habits and fitness reimbursements, • library of on-demand fitness videos, • Career Advancement Opportunities: Unlock your potential with clear paths for career progression and internal mobility across our diverse family of brands and business units., • Focused Learning and Development: Grow as a leader with our dedicated Learning and Organizational Development department, offering extensive resources like People Manager and leadership training, webinars, and eLearning courses., • Empowering Mentorship Program: Connect with colleagues through our company-wide mentorship program to share goals, overcome challenges, and drive your career forward., • Continuous Improvement Training: Participate in training that empowers all employees to learn and implement concepts that drive significant, positive change in the workplace., • Building a Healthy Society: To date, our co-Founders Lynda and Stewart Resnick, through their foundations and The Wonderful Company, have invested more than $2.5 billion in education, health and wellness, community development, and sustainability initiatives across California’s Central Valley, Fiji, and the world. In 2025, Wonderful ranked as #1 in PEOPLE’s “100 Companies That Care” list and was named one of Fortune magazine’s 100 Best Companies to Work For. To learn more about our corporate social responsibility efforts, visit csr.wonderful.com. The Wonderful Company’s connection to consumers has health at its heart and giving back at its core. The company has a long-standing commitment to corporate social responsibility, including more than $1 billion invested in environmental sustainability; $65 million in charitable giving, education initiatives, and innovative health and wellness programs each year; and $143 million toward the construction of two charter school campuses in California’s Central Valley. To view the current Corporate Social Responsibility report, visit . To learn more about The Wonderful Company, its products and its core values, visit , or follow us on Facebook, Twitter and Instagram. The Wonderful Company is an Equality Opportunity Employer that provides opportunities for advancement. We are committed to creating a diverse workforce that embodies a deep culture of acceptance, equity, and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories. #LI-hybrid EEO is the law - click here for more information

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes A DifferenceThe Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact • Ability to understand and follow institutional SOPs, • Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc., • Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct, • Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff, • Assist with planning and creation of appropriate recruitment and marketing materials, • Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc., • Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies, • Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives, • Assist in the creation or review of protocol specific source documents, • Determine facility, equipment and outsource vendor requirements and availability, • Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance, • Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks, • Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety., • Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies, • Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records, • Collect and evaluate concomitant medications, • Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual., • Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings, • Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave, • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials, • Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion, • Maintain effective relationships with study participants and other Care Access personnel, • Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management, • Strong and clear communication skills, both verbally and in writing, • Accept accountability for actions and function independently, • Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment, • Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial, • Administer delegated study questionnaires, where appropriate., • Collect and evaluate medical records with the support of medically qualified members of the study team., • Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol, • Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc., • Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion, • Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs), • Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol, • Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround, • Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance., • Monitor patient progress on study medication, • Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP, • Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion., • Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart, • Accurately transcribe data to CRF or EDC., • Resolve data management queries and correct source data as needed, • Record protocol exemptions and deviations as appropriate with sponsor., • Complete Note(s)-to-File for patient chart and regulatory filing if necessary, • Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing, • Maintain copies of patient-specific correspondence in source charts, • Assist regulatory personnel with completion of continuing/final review reports, • Perform other duties as assigned. The Expertise Required, • Excellent working knowledge of clinical trials, medicine and research terminology, • Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+, • Ability to communicate and work effectively with a diverse team of professionals, • Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail, • Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel., • Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc., • Critical thinker and problem solver, • Friendly, outgoing personality; maintain a positive attitude under pressure, • High level of self-motivation and energy, • Excellent professional writing and communication skills, • BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred, • RN or LPN preferred, • Research Professional Certification- CRCC or exam eligibility preferred, • A minimum of 3 to 4 years Clinical Research experience, • A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together, • Location: This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide., • Travel: Duties may require travel in the following models:, • Two weeks on / One week off deployments, • Temporary Event Support (3–7-day deployment durations), • Weekly deployments (one week on, 2-5 days off)., • Frequency and length of travel may depend on the length and location of study, site, and event. We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job Description Please note: This is a full-time, on-site position based in Fullerton. 2 years project coordinator preferred. Ecommerce project coordinating. Microsoft Excel assessment required. Overview of Job Description: The Product Development Project Coordinator is responsible for assisting and supporting all phases of Food, Wine and Gift packaging development from Concept to Production. The coordinator assists the Project manager, tracking timelines and milestones for multiple items in various stages of development throughout the year. This position interfaces with several departments and vendors to obtain product information to meet timelines. Primary Tasks and Responsibilities: • Assist with maintaining all Product Development schedules and timelines., • Initiate, maintain and update all Product Development Files., • Assist with Managing multiple projects at different stages of the development process., • Prepare Nutritional and technical file Inserts using Adobe Illustrator., • Create new component sheets for all Product Development packages., • Assist with proofing of all artwork, legal and FDA information on packaging, labels and informational sheets., • Review all vendors print proofs for mass production., • Create contents labels for towers/gifts (Wholesale & WC) using Adobe Illustrator and Bartender., • ·Assist with maintaining Nutritional & Kosher Libraries and Product files with updates., • Manage and support Label Group communications and requests to meet all Production timelines., • Work closely with the Purchasing team to obtain all Nutritional information: NFPs, ingredients and allergens/declarations., • Assist with proofing all Export labels and documentation., • Provide administrative support to the Project Manager as needed., • Assist with gathering all regulatory documents and cataloging., • Follow up with all teams on outstanding deliverables to meet timelines., • Possess strong written and verbal communication skills., • Possess a Basic understanding of Project Coordination and Management, • Ability to understand product specifications and measurements., • Ability to Type 40 WPM or More, • Highly Proficient with: MS-Office: Excel, Outlook, PowerPoint, • Ability to create and maintain complex/detailed spreadsheets., • Knowledge of Adobe Illustrator (preferred, but will train), • Ability to multi-task in a fast-paced environment., • Possess a clear sense of ownership and accountability in your responsibilities., • Possess attention to detail, problem-solving and accuracy., • Excellent time management skills., • Ability to prioritize and manage daily workload., • AA Degree or equivalent work experience · 2+ years in a Project Coordinator position Company DescriptionSince 1984, Houdini Inc. has been the leading supplier of upscale food and wine gifts to re-seller's throughout the U.S. Our trend-right gift assortments are found at America's foremost warehouse clubs, mass merchandisers, liquor retailers, specialty stores, catalog companies and internet sites.Since 1984, Houdini Inc. has been the leading supplier of upscale food and wine gifts to re-seller's throughout the U.S. Our trend-right gift assortments are found at America's foremost warehouse clubs, mass merchandisers, liquor retailers, specialty stores, catalog companies and internet sites.

Job Description Hiring Position: QA/RA Manager (Full-Time) Location: California About Hans Biomed USA, Inc. Hans Biomed USA Inc. is the U.S. branch of Hans Biomed Co., Ltd., a publicly traded company on the KOSDAQ exchange and a recognized innovator in medical devices and biologics. Headquartered in South Korea, our global operations span a diverse portfolio of products serving the aesthetics, cosmetics, dental, spine, and plastic surgery markets. With a strong foundation in research, quality, and regulatory excellence, we are committed to advancing patient outcomes and practitioner success across multiple specialties— Business Category: Aesthetics, Dermatology, Plastic Surgery, Cosmetics, and General Surgery Position Summary The QA/RA Specialist will play a critical role in ensuring regulatory compliance, maintaining and improving the Quality Management System (QMS), and supporting U.S. operations as an initial importer and distributor. This role requires fluency in Korean and English and hands-on experience with FDA, ISO, and AATB standards. Roles and Responsibilities (inclusive of; but not limited to) Regulatory Compliance & FDA Registration Management Monitor and implement regulatory changes (e.g., FDA QMSR, Cosmetic MoCRA) Ensure compliance with FDA regulations for QMS, HCT/Ps (21 CFR 1271), and AATB standards Prepare for and support FDA inspections and audits Manage compliance with Canadian regulations as an initial importer Oversee supplier qualification, evaluation, and documentation CAPA & Supplier Quality Management Investigate and manage non-conformities and CAPAs Respond to FDA allegations and implement corrective actions Support supplier audits and ongoing quality oversight Approval Process & QMS System Oversight Assume interim QRA Manager responsibilities as needed Oversee ERP approval rights and authorization workflows FDA Registration & Import Compliance Manage FDA establishment registration and device/tissue product listings Oversee annual license renewals for medical devices and HCT/Ps QRA Training & Internal Audits Deliver internal quality and FDA compliance training Conduct annual QMS reviews and internal audits Regulatory Documentation & Tracking System Maintenance Review product labeling and Instructions for Use (IFUs) Manage tissue tracking and device traceability systems in ERP AATB Certification & Tissue Bank Compliance Support HQ with AATB certification requirements and documentation Qualifications Minimum 3–5 years of experience in QA/RA in medical device, tissue, or cosmetics industries Bilingual proficiency in Korean and English (required) In-depth knowledge of ISO 13485:2016, 21 CFR 820, 21 CFR 1271, and MoCRA regulations Proficiency in ERP software & Microsoft Office Suite Experience with FDA inspections, internal audits, and supplier audits Strong document control, SOP writing, and QMS implementation skills Excellent communication and cross-functional collaboration abilities EMAIL: Benefits • Lunch: $250 per month ($3,000 annually), • Gas: $100 per month ($1,200 annually), • Medical, dental, and vision insurance 100% covered for the employee only (after 3-month probation period), • 401K up to 3% match – vested after 1 year (after 3 months of employment), • 5 Vacation and 12 Sick Days, • 15 Paid Holidays

Job DescriptionEssential Duties and Responsibilities: Includes the following. Other duties may be assigned. Performs all tasks and assignments in a safe and timely manner. Strives toward continuous self-improvement in personal productivity. Develop and maintain supplier quality assurance programs aligned with FDA, ISO 22716 (GMP for cosmetics), and other applicable regulations. Conduct supplier audits, assessments, and risk evaluations to ensure compliance with quality standards. Collaborate with Supply Chain, R&D, Quality and Regulatory Affairs to qualify new suppliers and manage ongoing supplier performance. Lead investigations into supplier-related non-conformances and drive corrective and preventive actions (CAPA). Monitor and report supplier KPIs including defect rates, delivery quality, and responsiveness. Implement and manage supplier scorecards and continuous improvement initiatives. Ensure proper documentation and traceability of supplier quality records. Stay current with industry trends, regulatory changes, and emerging risks in the OTC/cosmetics supply chain. Collaborate with cross-functional teams to support continuous improvement initiatives. Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements. Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Reviews subordinate performance in a formal review process. Support audit preparedness and internal audit programs, as well as regulatory and customer audit inspection readiness. Preferred: ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ISO 13485 Lead Auditor Certification. Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Willingness to travel to company and vendor facilities as needed, approximately 25%. qualifications: Minimum 5 years of relevant experience in engineering, quality assurance, or manufacturing supplier quality in regulated manufacturing environment (cosmetics or OTC drugs a plus). Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences). Working knowledge of Six Sigma and/or Lean Manufacturing principles. Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/ 210/ 211), including data integrity and practices. Proficiency in quality tools and methodologies, including Supplier Assessments, First Article Inspections (FAI), Failure Modes and Effects Analysis (FMEA), 8D Problem Solving, Root Cause Analysis, Corrective and Preventive Actions (CAPA), Mistake Proofing and Process Control. Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Strong attention to detail and organizational skills. Effective written and verbal communication skills. Proficiency in Microsoft Office and familiarity with electronic quality systems. Adheres to all Prime Personnel Policies as established by the company. Physical Requirements: • Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance., • Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts., • Good understanding of safety protocols and practices., • Willingness to work flexible hours, including shifts and weekends. At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer. Powered by JazzHR n6JxXoEQ31

Job Description Overview The Equipment Calibration and Qualification Technician performs calibration and qualification of research and manufacturing equipment, ensuring regulatory compliance with FDA's 21 CFR Part 820 and ISO 13485, and compliance with other standards. Responsibilities include calibrating equipment, executing qualification protocols, maintaining calibration records, coordinating external services, and supporting validation activities. The role requires hands-on work with precision measurement tools, strong attention to detail, regulatory knowledge, and excellent documentation skills. This full-time, on-site position also involves assisting with other Quality Assurance and validation tasks as needed. Reports to: Vice President of Quality Assurance & Regulatory Affairs Duties and Responsibilities: The Equipment Calibration and Qualification Technician's responsibilities include: • Managing all calibration of manufacturing and laboratory equipment, including torque wrenches, pressure gauges, temperature sensors, analytical balances, micrometers, calipers, and other precision measuring instruments., • Ensuring all calibrated equipment is labeled and that calibration or qualification has not expired., • Maintaining accurate calibration records, certificates, and documentation in compliance with FDA 21 CFR Part 820, ISO 13485., • Updating the equipment database with the current qualification and requalification status,and using it to ensure the timely completion of all activities, whether performed internally or externally., • Providing calibration and qualification status reports and metrics to management and support teams., • Writing, performing, and documenting equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Preventive Maintenance (PM)., • Supporting validation activities for new equipment, as well as modification or relocation of existing equipment., • Supporting internal and external audits by providing calibration and qualification documentation, technical expertise, and responses to audit findings related to measurement systems and calibration processes., • Participating in corrective and preventive action (CAPA) investigations related to calibration and qualification non-conformances, equipment failures, and measurement system issues. The Equipment Calibration and Qualification Technician should use existing skills to perform calibration and qualification procedures, maintain documentation, and ensure regulatory compliance in individual and team projects. The following abilities may assist in completing these tasks. • Proficient with precision measuring instruments, including micrometers, calipers, torque wrenches, pressure gauges, temperature sensors, analytical balances, and electronic test equipment for calibration activities., • Strong computer skills, such as proficiency in Microsoft Office Suite for documentation, reporting, and data analysis, as well as experience with database systems for tracking equipment status, maintaining records, and generating reports and certificates., • Experience with calibration principles, measurement uncertainty concepts, and statistical analysis of measurement data for equipment performance evaluation., • Understanding of national and international measurement standards (NIST, ISO 17025) and traceability requirements for calibration activities., • Familiar with medical device manufacturing regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP)., • Knowledge of equipment qualification processes (IQ/OQ/PQ) and validation documentation requirements in regulated manufacturing environments., • Experience with metrology equipment maintenance, storage, and handling procedures to ensure measurement accuracy and equipment longevity., • Ability to read and interpret technical drawings, specifications, calibration procedures, and equipment manuals for various measuring instruments., • Problem-solving abilities to troubleshoot calibration issues, identify root causes of equipment failures, and recommend corrective actions., • Highly organized with strong attention to detail and time management skills., • Excellent written and verbal communication skills for documentation, reporting, and coordination with cross-functional teams., • Ability to work independently while following established procedures and collaborate effectively with quality, engineering, and manufacturing teams., • Associate or Bachelor's Degree in Engineering Technology, Electronics, Instrumentation, Metrology, or related technical field., • 2+ years' experience in calibration, metrology, or instrumentation, preferably in the medical device, pharmaceutical, or other regulated industry., • 2+ years of hands-on experience with precision measuring instruments and calibration equipment in a manufacturing or laboratory environment., • ASQ Calibration Technician Certification or equivalent industry certification., • NCSL International training certificates in calibration and measurement principles., • Experience with equipment qualification (IQ/OQ/PQ) processes in FDA-regulated manufacturing environments., • Knowledge of ISO 17025 laboratory accreditation requirements and measurement management systems. To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Benefits: • 401(k) Safe Harbor Plan, • Healthcare Insurance: Medical, Dental and Vision, • Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance, • Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave, • Tuition Reimbursement Program, • Performance Bonus, • Flexible Schedule Salary $55,000 - $85,000 per year Privacy Policy | Critical Innovations

Job Description About This Role RDI is seeking a detail-oriented and motivated Senior Clinical Research Associate (CRA) to join our dynamic team. In this role, you will act as a critical link between the clinical sites and our research teams, ensuring that all clinical trials are conducted according to regulatory guidelines, protocols, and ethical standards. You will have the opportunity to work closely with investigators and other health professionals to monitor and evaluate study progress, data integrity, and patient safety. About RDI RDI is a nimble, full-service CRO focused on accelerating in vitro diagnostic (IVD) development. We bring together clinical sites, physicians, and our own CLIA-certified, CAP-accredited lab to help diagnostics innovators run smarter, faster studies—without the friction. Our team supports everything from study startup to FDA submission, ensuring sites are equipped, patients are cared for, and timelines stay on track. At RDI, every role is tied to real-world impact: whether you’re working with a physician site or on a client call, you’re helping bring critical diagnostics to patients faster. We’re a team that values clarity, ownership, and moving as one—so if you’re ready to grow and want to do meaningful work, you’ll feel right at home here. Responsibilities • Conduct site visits including initiation, monitoring, and closeout activities to ensure compliance with protocol and regulatory requirements., • Collaborate with investigators and site staff to provide training on protocols and study-related procedures., • Review and verify clinical data for accuracy and completeness in accordance with Good Clinical Practice (GCP)., • Prepare and maintain necessary documentation, including progress reports, to keep all stakeholders informed about study status., • Identify and resolve site issues, discrepancies, and non-compliance matters promptly to ensure study integrity., • Assist in the selection and evaluation of study sites to ensure suitability for clinical trials., • Manage study supplies and ensure timely delivery to clinical sites, maintaining an effective inventory., • Lead internal and client-facing study calls, track follow-up actions, and maintain study documentation including meeting minutes., • Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred., • At least 2 years of experience as a Clinical Research Associate or similar role in the clinical research industry., • The ability to travel up to 30%., • Strong knowledge of Good Clinical Practice (GCP) and regulatory guidelines., • Excellent communication, interpersonal, and presentation skills., • Ability to travel to various clinical sites as required by the study protocol., • Strong organizational skills and attention to detail in managing multiple priorities., • Health Care Plan (Medical, Dental & Vision), • Retirement Plan (401k, IRA), • Life Insurance (Basic, Voluntary & AD&D), • Paid Time Off (Vacation, Sick & Public Holidays)

Job Description Senior CRA – Los Angeles C-Clinical is seeking an experienced Senior Clinical Research Associate to support studies in the Los Angeles region. This position blends remote monitoring with on-site visits, offering flexibility while ensuring high-quality oversight. We are looking for professionals with a strong background in CNS, oncology, or metabolic indications who understand the importance of regulatory compliance, protocol adherence, and effective site relationships. The right candidate will be detail-focused, proactive, and motivated to help drive research forward. At C-Clinical, we believe in meaningful work that impacts lives. Our culture is built on integrity, teamwork, and purpose, and we are excited to welcome individuals who share that vision. If you’re an experienced CRA in the Los Angeles area ready to contribute to a growing, mission-focused organization, we invite you to apply. Next Step: After submitting your application, please complete the brief introductory survey sent via email. Compensation: $65 - $95 hourly Responsibilities: Sr. CRA – Los Angeles Area (On-site/Hybrid) • Interfaces with the study team to ensure timely initiation and completion of clinical trials, • Responsible for the identification, evaluation, and qualification of investigators and sites in the Los Angeles area and surrounding region, • May prepare and submit essential document packages required for clinical site initiation, • Performs on-site monitoring activities for clinical trials and escalates site issues to the Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in monitoring reports and follow-up correspondence, • Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets, • May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance, • Ensures the protection of research subjects by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements, • Identifies, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensures all applicable SAEs are reported to sponsor and regulatory authorities, • Ensures the accuracy and integrity of the data submitted on electronic or paper case report forms (CRFs), or other data collection tools, through comprehensive source document review. Monitors study databases for missing or discrepant data compared to source records, • Ensures that all required monitoring tasks are conducted according to site SOPs, established guidelines, work instructions, and project-specific plans (e.g., monitoring plan), • Maintains study blinding and serves as a blinded study monitor as needed; conducts eCRF/CRF review, query generation, and resolution based on established data review guidelines, with or without direct supervision, • Attends investigator meetings, project team meetings, and teleconferences as needed, • Understands and applies knowledge regarding local, state, and federal regulations (e.g., FDA, ICH-GCP), • Maintains current training on ICH-GCP, study protocols, and internal procedures, • May track regulatory documentation, monitor site recruitment, assess study site quality and compliance, and help motivate assigned sites to meet study timelines and goals Qualifications: • 3 years or more as a CRA with site monitoring responsibility and 1 year or more CNS Or • 3 years or more as a CRA with site monitoring responsibility and 1 year or more in either: Phase 1, a complex indication with in-patient monitoring, Or metabolic studies Or • 3 years or more as a CRA with site monitoring responsibility and 1 year or more in Oncology Monitoring And • The candidate possesses a 4-year university degree, ideally in a scientific field, • In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, nursing/possibly another medical certification, and 5 years of monitoring in a complex indication (inpatient, oncology, phase 1, etc.) may be considered, • Must have working rights in the United States, • Must be located within the greater Los Angeles area, • The candidate must have availability for at least 1 year, • Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology, • Bilingual is a plus, • Corp to Corp, • Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication, • Note: the travel rate is 50% regular rateAbout Company C-Clinical in Los Angeles drives clinical operations excellence across the pharmaceutical, biotechnology, and device sectors. Our chief concept is in guiding relationships and directing the government. We go by "love" in the principle: love your neighbor as yourself, and charity. C-Clinical was not an act of compulsion, but the care one would have for family. Bottom line - we created this company to do what we love to do: life-changing medical research, and to dedicate our time, talents, and resources to those who need them.

Job DescriptionVolt is immediately hiring a Mechanical Design Engineer in Torrance, CA. Incredible opportunity with a leading manufacturing company in Torrance that is making a real impact. They are looking for a Mechanical Design Engineer who is passionate about innovative design and thrives in engineering analysis and testing to ensure product durability. As Mechanical Design Engineer you will: Launch new products from concept to manufacturing. This is a great opportunity to take your understanding of materials and tolerancing to design for manufacturability. This is an opportunity to design, test, and work with vendors to ensure a successful product launch. • Create 3D models, 2D drawings, and BOM’s using SolidWorks / PLM, • Conduct and/or support engineering analysis, simulation, and physical testing to ensure, • the strength, durability, and safety of product designs., • Create and manage detailed BOM readiness planning including cost, mass, and timing, • Collaborate with suppliers to proactively resolve technical issues to ensure on-time and quality first articles and production This is a Full time, Direct Hire opportunity. The ideal candidate will have: • Experience designing and launching mechanical products ( 2-4 years of vendor management, • SolidWorks experience, • Design for manufacturability experience (tubing, welding, machining, assembly), • Lab physical testing – strength, durability, regulatory (ISO / FDA / MVSS or similar) ASME Y14.5-1994 GD&T, • SolidWorks kinematics is a plus!Salary: $95K-$120K/ per year *Salary range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please call (866) -898-0005. Please indicate the specifics of the assistance needed. Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Job Description Job Title: Senior Manager, Regulatory Strategy Location: Azusa, CA Position Type: Full-time Exciting opportunity to join a dynamic and innovative Cosmetics company - the team is committed to excellence and continuous improvement in all aspects of the business, but most importantly QC/Regulatory. As the team expands operations, they seek a highly qualified and experienced Senior Manager, Regulatory Strategy to join the team. Job Summary: The Senior Manager, Regulatory Strategy will play a crucial role in ensuring our compliance with regulatory requirements, optimizing our product development processes, and guiding strategic decision-making. Reporting to the VP of QC/Regulatory Affairs, this position requires a candidate with strong leadership skills, a deep understanding of regulatory frameworks, and the ability to collaborate cross-functionally to achieve regulatory compliance objectives. Key Responsibilities: • Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies that align with the company's business goals. Stay up-to-date with industry regulations and trends to anticipate potential impacts on the organization., • Product Compliance: Lead efforts to ensure that all products meet regulatory standards and requirements, including submissions, approvals, and post-market surveillance activities., • Cross-functional Collaboration: Collaborate with cross-functional teams, including R&D, Quality Assurance, Legal, and Marketing, to integrate regulatory considerations into product development and commercialization processes., • Regulatory Submissions: Prepare and submit regulatory documents, including 510(k)s, PMAs, INDs, NDAs, and international submissions as needed. Maintain communication with regulatory authorities to facilitate approvals., • Risk Assessment: Conduct risk assessments to identify potential regulatory issues and develop mitigation strategies. Provide guidance on risk management throughout the product lifecycle., • Regulatory Intelligence: Monitor changes in regulatory requirements, industry guidelines, and competitive landscapes to provide insights and recommendations for proactive compliance measures., • Team Leadership: Manage and mentor a team of regulatory professionals, fostering a collaborative and growth-oriented work environment., • Audit Preparation: Prepare the organization for regulatory audits and inspections, ensuring all documentation and processes meet regulatory standards., • Compliance Reporting: Generate reports and metrics to track regulatory compliance and provide regular updates to senior leadership. Qualifications: • Minimum of bachelor’s degree in Chemistry or other science disciplines, • 10-12 years of experience in regulatory affairs preferably in a cosmetic or personal care products company; additional experience in quality control is a plus, • 5-7 years of related supervisory/management experience to include building and developing teams, • Must have 5-7 years’ experience as an active participant with cosmetic-centric FDA audits, • Must be a practitioner of and have a solid understanding of regulations surrounding cosmetics including US-FDA, FPLA (Fair Packaging and Labeling Act), FDC (Food, Drug, & Cosmetic Act), EU Cosmetic Regulation 1223/2009, and Health Canada, • Competitive salary and performance-based bonuses., • Comprehensive benefits package, including health, dental, and retirement plans., • Professional development opportunities., • Dynamic and inclusive work environment. Location: this position is an onsite role in the Greater Los Angeles area.

Job Description In April 2025, Kandu Health and Neurolutions merged to form Kandu Inc. to pioneer an integrated approach to stroke recovery, combining FDA-cleared brain-computer interface technology with personalized telehealth services. The company’s IpsiHand® device is durable medical equipment that enables chronic stroke survivors to regain upper extremity function in daily home use. Combining this advanced technology with the support of expert clinicians offers a comprehensive path to recovery– helping survivors improve mobility, independence, and quality of life. Kandu extends recovery beyond the hospital through principal illness navigation, providing one-on-one education, care coordination, and advocacy; grounded in clinical evidence and informed by the lived experiences of patients and their families. The SVP, Payer Relations & Strategy will architect and lead enterprise payer strategy and reimbursement operations. Reporting to the CEO, this executive will create and execute a multi-year roadmap to secure prior authorizations, cultivate senior payer relationships, and drive payment success across Medicare, Medicare Advantage, Medicaid, and commercial insurers. The role sets segmentation and policy priorities, approves negotiation frameworks, and builds a scalable access organization that makes our therapy broadly accessible and affordable. What You’ll Do Strategic Leadership • Develop and lead the comprehensive payer and market-access strategy & operations for the company’s current and pipeline products., • Serve as the internal expert on payer policy, reimbursement trends, and regulatory dynamics for durable medical equipment and digital health services., • Stay current on state and federal policy changes and convert them into strategic growth recommendations., • Lead payer segmentation, targeting, value-proposition development, and contracting prioritization, delegating tactical execution as needed., • Develop strategies to optimize market access and reimbursement rates; ensure plans feed directly into corporate forecasts and operating plans., • Monitor payer policies, market trends, and competitive moves to surface risks and opportunities., • Direct coverage-policy, coding, and pricing analyses to support current and future products.Payer Engagement, • Bring established relationships with key decision makers at leading commercial and government health plans—executives, medical directors, policy committees, and case managers—and expand these networks to accelerate adoption., • Drive contracting efforts, including gap exceptions and single-case agreements, with a goal of achieving in-network status on favorable terms., • Design and deliver educational programs that highlight the clinical and economic value of the company’s therapies.Operational Execution, • Develop a three-year blueprint for benefit verification, prior authorization, appeals, and billing/collections that can scale efficiently with projected year-over-year growth, including scenarios that double current volume., • Identify process gaps and close them via technology, automation, or strategic partnerships; ensure consistent adoption of new procedures across all teams while overseeing day-to-day execution., • Maintain audit-ready documentation and controls, ensure proactive compliance with all payer and regulatory requirements, and own the functional budget and staffing plan.Evidence & Policy, • Collaborate with Clinical and Medical Affairs to convert outcomes data into payer-ready dossiers., • Partner with external advisors and KOLs to develop medical-necessity criteria and secure favorable policy inclusion and coverage determinations.Cross-Functional Collaboration, • Align Sales, Marketing, Clinical, and Product functions with market-access strategy., • Influence product design and go-to-market plans with payer and provider insights, and participate in budget and forecasting efforts to ensure accurate payment timing and revenue projections.Metrics & Reporting, • Define and track KPIs such as prior-authorization approval rate, time to payment, overturned-denial percentage, and payer-specific conversion., • Analyze marketing and relationship spend for ROI, and provide regular updates to the executive team and Board., • 8+ years in healthcare reimbursement, market access, or payer contracting—ideally in medical devices, durable medical equipment or digital therapeutics., • Demonstrated success launching novel therapies with new HCPCS or CPT codes and achieving national coverage., • Deep knowledge of CMS policy, HCPCS coding, and payer dynamics, with extensive experience negotiating at the Medicare Advantage and large commercial-payer level., • Executive presence and a history of Board and investor presentations., • Proven ability to build and lead high-performing market-access and revenue-cycle teams., • Experience with CMS CED Programs a plus. What We Offer • Competitive Compensation ($200,000 - $250,000 DOE + bonus), • Insurance (Medical/Dental/Vision), • 401(k) with company, • Unlimited PTO & Holidays, • Life Insurance, LTD and STD Please note that the salary information is a general guidance only. Kandu Health, Inc. considers factors such as scope and responsibilities of the position, candidate’s work experience, education/training, key skills and internal parity, as well as location, market and business considerations when extending an offer. Kandu Health is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Powered by JazzHR wFhnoMPlTv

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together to form something truly special. When you decide to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring experienced motivated and hands-on engineers, experienced in commissioning, qualifying, and validating pharmaceutical manufacturing facilities, utilities, equipment, and systems. Our engineers play a critical role in driving project success through developing and executing protocols, identifying and mitigating risks, operating and troubleshooting equipment, and generating project lifecycle documentation, while ensuring regulatory standards and quality compliance. • Develop and execute commissioning, qualification, and validation protocols for required equipment and systems., • Generate, review, and/or author all required technical documentation including IQ/OQ/PQ protocols, operating procedures, specifications (URS, FS, DS), risk assessments, reports, and so on., • Collaborate with cross-functional teams to ensure validation activities are aligned with project timelines and regulatory requirements., • Conduct risk assessments, impact assessments, and gap assessments, identifying potential risks and implementing mitigation strategies., • Analyze test results, data, and acceptance criteria to ensure accuracy., • Troubleshoot and operate required equipment to support start-up activities and evaluate process performance. Ensure appropriate equipment/system modifications as needed., • Additional responsibilities as required to drive project deliverables. Requirements • Bachelor's degree in related engineering discipline., • 2-5 years of experience executing commissioning, qualification, and validation for a range of equipment and systems within the pharmaceutical and/or biotechnology industries., • Experienced writing and generating technical validation documentation including IQOQPQ protocols, specifications (URS, FS, DS), operating procedures, etc., • Proven knowledge of regulatory requirements and industry standards (cGMP, FDA, etc.)., • Strong understanding of risk-based validation approach., • Proactive and motivated with the ability to manage multiple tasks /projects., • Excellent problem-solving, analytical, and technical skills., • Strong time management and organizational abilities., • Effective communication and interpersonal skills., • Detail-oriented mindset with a commitment to maintaining high-quality standards., • Ability to work independently and as part of a team., • Must be able to work extended hours., • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. BenefitsAdhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $85,000 - $100,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement: PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RD1

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role Senior CQV Engineers are responsible for leading commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. Our Senior CQV Engineers play a critical role in overseeing project planning, CQV execution, and ensuring the operational readiness of capital projects in order to support our clients’ success. • Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues., • Develop and execute commissioning, qualification, and validation protocols for required equipment and systems., • Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures., • Identify and assess risks associated with CQV activities and develop mitigation strategies., • Troubleshoot and resolve issues related to equipment and process performance., • Collaborative with cross-functional teams to ensure alignment of CQV activities and project timelines., • Serve as liaison between vendors and contractors, coordinating required hand-offs., • Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.)., • Provide ongoing support and technical expertise through validation execution and qualification activities., • Additional responsibilities as required. Requirements • Bachelor’s degree in engineering or a related field., • 7+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries., • Well-rounded, versatile equipment and systems experience. Experience with clean-room facilities and process equipment preferred., • Proven success in leading CQV projects and experience with project management methods and tools., • Advanced knowledge of regulatory requirements and industry standards., • Well-versed in validation lifecycle management and risk-based approaches., • Excellent analytical and technical problem-solving skills. Ability to analyze project risks effectively and implement resolutions., • Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.), • Effective communication and interpersonal skills. Ability to manage stakeholder communication and cross-functional team collaboration., • Proactive with strong organization and time management skills., • Excellent attention to detail with commitment to quality and compliance., • Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents, • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more., • 401(k) and 401(k) matching, • PTO, Sick Time, and Paid Holidays, • Education Assistance, • Pet Insurance, • Discounted rate at Anytime Fitness, • Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $100,000 – $120,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-JL1

Job DescriptionBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Cleaning Validation Specialist to work for a leading Greater Los Angeles area contract development and manufacturing organization. Salary: $90-100k+/year depending on experience Responsibilities: • Develop, write, and review cleaning validation protocols, reports, and standard operating procedures (SOPs) in accordance with GMP regulations and global procedures., • Establish acceptance criteria for cleaning validation based on product residues, cleaning agents, and microbial contaminants., • Plan and execute cleaning validation studies, including surface sampling, rinse sampling, and swabbing of equipment and facilities., • Conduct analytical testing associated to cleaning validation, to include Total Organic Carbon (TOC) testing, • Coordinate with production and quality control to schedule and perform validation activities., • Analyze cleaning validation data to ensure compliance with established acceptance criteria., • Prepare detailed validation reports summarizing findings, deviations, and corrective actions., • Ensure all cleaning validation activities comply with relevant GMP guidelines, including FDA, EMA, and other regulatory bodies., • Align local site-based procedures with global SOP’s., • Stay current with regulatory updates and industry best practices related to cleaning validation., • Identify opportunities for process improvements in cleaning procedures and validation practices., • Participate in root cause analysis and implement corrective and preventive actions (CAPAs) for cleaning validation deviations., • Provide training to production and quality staff on cleaning procedures and validation requirements., • Maintain comprehensive and up-to-date documentation of all cleaning validation activities., • Work collaboratively with production, quality assurance, quality control, and regulatory affairs to ensure cleaning validation requirements are met., • Site representative for the global cleaning validation team to align on bets practices, globally, • Support internal and external audits related to cleaning validation processes.Experience/Requirements:, • BA/BS in Chemistry, Microbiology, Engineering, or a related field; advanced degree preferred, • 3-5+ years of experience in cleaning validation within a GMP-regulated pharmaceutical manufacturing environment

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes A DifferenceThe Clinical Research Assistant for the Future of Medicine program is an entry-level clinical position designed to fully integrate individuals into the Care Access research process. The Future of Medicine program brings clinical trials directly into communities, making research more accessible and inclusive for diverse populations. As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at regional events (with travel up to 25%). This role offers opportunities for growth and advancement within the Care Access Research organization. How You'll Make An Impact • As a Clinical Research Assistant, you'll support every stage of the research process: engaging with participants and collecting biospecimens, to managing data and maintaining regulatory compliance. You'll help bring clinical trials directly into local communities by supporting recruitment, outreach, and event operations. Along the way, you'll gain hands-on experience in clinical research with opportunities to grow your skills and career., • Clinical & Participant Care, • Perform independent venipuncture, including managing difficult draws and re-attempts per protocol., • Collect, label, process, package, and ship biospecimens while maintaining chain of custody and temperature controls., • Obtain informed consent under the direction of the Clinical Research Coordinator (CRC)., • Complete protocol-required visit procedures under CRC direction., • Communicate clearly with participants and on-site teams; escalate issues promptly., • Maintain effective, professional relationships with participants, investigators, and sponsor representatives., • Study Operations & Data Management, • Record and enter data in real time on paper or e-source documents, ensuring accuracy and legibility., • Request and manage medical records for potential and current participants., • Update study trackers, online recruitment systems, and site logs., • Request and issue study participant payments., • Maintain adherence to FDA regulations, ICH guidelines, and institutional SOPs., • Member Education & Community Engagement, • Participate in member education and pre-screening events, which may occur at multiple locations., • Set up and tear down event sites; prepare kits and supplies, ensuring aseptic technique and biohazard safety., • Assist with distribution of outreach and education materials., • Schedule participant visits and provide reminders., • Clinical Site & Administrative Support, • Assist with administrative tasks such as copying, scanning, filing, mailing, and emailing., • Support inventory management and ordering of equipment and supplies., • Contribute to maintaining an organized, compliant site environment., • Other Responsibilities, • Communicate clearly in both verbal and written form., • Perform other duties as assigned in support of study success. The Expertise Required, • Technical & Operational Proficiency, • Comfortable using eSource/mobile apps and standard office tools., • Proficiency in Microsoft Office Suite., • Ability to learn and adapt in a fast-paced, evolving environment., • Strong organizational skills with close attention to detail., • Professional & Interpersonal Skills, • Excellent verbal and written communication skills with a high degree of professionalism across diverse groups., • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure., • Critical thinker and problem solver with strong initiative., • Ability and willingness to work independently with minimal supervision while contributing effectively to team and site goals., • Clinical Skills & Experience, • 1+ year of recent, hands-on phlebotomy experience in a clinical setting (≥200 venipunctures; ≥25–50 capillary sticks; ≥30–50 in the last 2–3 months)., • Demonstrated competency in specimen processing., • Working knowledge of medical and research terminology, ICH-GCP, HIPAA/PHI handling, and related federal regulations., • Some prior clinical research experience preferred., • Current national phlebotomy certification, such as:, • ASCP Phlebotomy Technician (PBT), • AMT Registered Phlebotomy Technician (RPT), • NHA Certified Phlebotomy Technician (CPT), • NCCT National Certified Phlebotomy Technician (NCPT), • State-specific licensure/certification if required (CA, WA, LA, NV). How We Work Together, • Location: This position is for a full-time, hourly role. The standard schedule is Tuesday through Saturday, averaging 32–42 hours per week. Work is typically split between community events and a local clinical site (for example, a Houston-based team member may spend three days at community events and two days at the local site) We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job DescriptionTester Salary$25 an hourJob TypeContract Be part of a company that delivers life-changing healthcare solutions. Sapta is looking for a QA Specialist for our client in New Brunswick, NJ.Sapta’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!Position Overview:This role is an 18 to 24 month opportunity to gain experience with Bulk Drug Substance manufacturing.The Senior Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support.You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release.This position may also be cross trained to cover other QA functions as needed.Responsibilities:Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.Assists with Document Control and other QA functions.Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings.Gives guidance to CMO as needed and ensure CMO is compliant with Client Quality standards.Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.Escalates critical quality problems to Senior Management in a timely manner.Qualifications:BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language.Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.Ability to Coordinate Quality oversight and working with other site groups.Ability to review Quality documents and ensuring compliance to GMP. Documents to include batch records, logs, and others.Ability to be an effective communicator to Management, and line staff.Ability to work with other manufacturing teams to implement business objectives.Must be very detail oriented and be able to quickly detect errors within documentation.

Job DescriptionAbout CookUnity Food has lost its soul to modern convenience. And with it, has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The Role While believing that healthy food fuels stronger communities, we are looking for an energetic and innovative Senior Food Scientist within our Food Safety and Quality Assurance (FSQA) team. The FSQA team plays a key role in our kitchens, responsible for monitoring and verifying that food production adheres to regulatory, safety and quality standards. The FS will develop, improve, and ensure the safety and quality of RTE products by utilizing scientific principles to study food composition and optimize processing methods. Their duties also include ensuring compliance with claims, food labeling regulations and FDA/USDA standards. Responsibilities • Ensure compliance with all regulatory requirements related to labeling, certifications and claims to comply with existing and new regulatory requirements., • Research and implement new food technologies, emerging ingredients, and process improvements to enhance product differentiation., • Act with urgency to address consumer requests, feedback and quality concerns through product and process enhancements and modifications., • Develop standards and specifications for food production, testing, shelf life studies, sanitation, and waste management., • Maintain high standards for the company's food safety and handling practices, constantly seeking ways to improve processes with scalable solutions, • Stay up to date on current local and national guidelines that will inform training and operating protocols, business impact and leadership awareness., • Coordinate inspections with local authorities and achieve high ratings from the health department., • Lead human taste panels to evaluate the flavor, texture, and appearance of food products involving information about consumer preferences and attitudes toward food products to inform product development and marketing strategies., • Creating guidelines for new products or modifying existing ones to meet consumer preferences and market trends such as clean label, reduced sugar, plant-based, or allergen-free requirements. This role requires approximately 30% travel for in-person site visits Qualifications • Bachelor's in food science (chemistry/microbiology/processing), or related field., • Proven track record of successful product development and commercialization., • 10+ years of experience in food product development with demonstrated expertise in testing methodologies, sensory evaluation, and shelf-life analysis., • In-depth knowledge of food safety regulations and quality assurance practices., • Excellent project management abilities. Adept at problem-solving and analytics., • Strong communication and presentation skills., • Preferred: Experience in culinary, food preparation, meat/protein processing, ready-to-eat foods, refrigerated foods, ready-to-heat foods., • Nice to have: Bilingual (Spanish)Benefits, • 🩺 Health Insurance coverage, • ⛱ PTO policy and paid sick days, • 📈 We grow, you grow: Stock Options Plan granted on Day 1., • 🌟 Eligible for bi-annual performance bonus, • 🐣 Family leave fully paid, • 🕯 Compassionate Leave: 3-5 days each time the need arises, • 🥘 A generous amount of CookUnity credits to enjoy our amazing meals, added to your account, monthly, • 🧘🏽️‍♀️ Customize the benefits that suit your needs! Access a range of perks tailored to you, including learning opportunities, wellness memberships, delivery apps, and more through our comprehensive benefit platform, • 👩🏾️‍🏫 Personalized Spanish coach, • 🌟 Awesome opportunity to join a company that is looking to change how we eat and how chefs work! 🗓️ 5- year Sabbatical: After 5 years with CookUnity, you get a 4-week paid sabbatical Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$100,000—$130,000 USD If you're interested in this role, please submit your application and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines, and develop and execute regulatory plans. This position will report to the Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions. Responsibilities • Lead the preparation and submission of global regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.), • Participate or lead the preparation for Health Authority interactions, • Collaborate with the global regulatory lead and regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications., • Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions., • Work with regulatory leads to monitor timelines and key program activities and tracking submission deliverables to maintain target submission dates., • Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines, • Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders., • Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams, • Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals, • Education equivalent to a BS or MS, plus 5 years of hands-on regulatory experience,, • Education equivalent to a higher degree (PharmD or PhD), plus 3 years of hands-on regulatory experience,, • Knowledgeable in ICH and FDA guidelines relevant to device and combination product CMC aspects of product development., • Ability to manage complex projects and timelines in a collaborative matrix team environment., • Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills., • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors., • Experience with international regulatory submissions All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Leading manufacturer and distributor of beauty and personal care products seeks a Regulatory Manager. This is a full-time and onsite position; no hybrid option. Job description: You will play a key role in overall product compliance as it applies to domestic and international markets. The ideal candidate must have the ability to stay knowledgeable & current with industry regulations and how to integrate them into the current business model. You will coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met. Research scientific and regulatory information to write, edit, and review reports. Key Duties and Responsibilities: · Prepares international regulatory submissions, progress reports, supplements and amendments, license renewal and annual registrations. · Obtains Certificates of Product for Export or other applicable export notifications from the FDA as needed. · Keeps abreast of changes and proposed changes to the worldwide regulatory requirements related to products and processes. · Coordinates, compiles, and provides submission documents for global regulatory filings, utilizing good understanding of global regulations for cosmetic products. · Organizes and maintains regulatory files with records required to meet federal and international guidelines · Develops and maintains regulatory library containing company specific documents, reference articles, etc., as well as on-site archived regulatory submissions documents. · Ensures complete customer satisfaction with all company products within assigned territory. · Advises the registration team on how to place products into certain markets, answer questions regarding product registration, and justify product ingredients. · Creates Quality documentation: C of A, stability, specification, as well as assisting quality with interpreting test results. · Experience in collecting, writing, revising, and converting MSDS (material safety data sheets) to SDS (safety data sheets) highly preferred. · Familiarity with handling CARB (California Air Resources Board) Survey. · Create and review regulatory documentation including, but not limited to, ingredient listing, quantitative and qualitative documentation, & label claim review. · Other duties as required. Education/Experience Necessary: • Bachelor’s degree in Chemistry, Life Science, Engineering, or related discipline preferred. Senior Specialist level., • Minimum 5-7 years of experience within Quality or Regulatory, Quality, or Product Development in cosmetic/pharmaceutical manufacturing highly preferred., • Associate level: 3 -5 years of Regulatory experience., • Working knowledge of cosmetic regulatory requirements in domestic and international markets., • General understanding of overall manufacturing and quality processes., • Excellent verbal and written communication skills., • Superior organizational skills, • Strict attention to detail and follow-through, • Ability to work independently, • Ability to multi-task, • Experience in the preparation and regulatory submissions is an asset, • Knowledge of DOT/IATA/IMDG and experience with CARB/VOC/EPA preferred., • Excellent computer skills including Microsoft Office applications Headquartered in Los Angeles, California, we are at the heart of beauty and fashion. Our continued access to the latest trends has given way to fresh and innovative products. Our corporate headquarters occupy approximately 250,000 square feet and are comprised of executive and administrative offices, warehousing and on-site manufacturing and distribution facilities. Our product lines include Andrea, Ardell, Body Drench, Checi, China Glaze, Clean + Easy, Clubman, EzFlow, Fright Night, Gena, GiGi, ibd, 'N Rage, ProLinc, SuperNail, Surgi-Care, Tres Flores, and Youthair to name a few. With over 60 brands, our niche products reach all segments of retail, beauty-supply, grocery, boutique and specialty markets in over 180 coAmerican International Industries is the leading manufacturer and distributor of innovative, quality beauty and skin care products for men and women. With fifty-plus years of industry experience, we understand what it takes to be successful in the competitive and ever-changing world of beauty.\r\n\r\nHeadquartered in Los Angeles, California, we are at the heart of beauty and fashion. Our continued access to the latest trends has given way to fresh and innovative products. Our corporate headquarters occupy approximately 250,000 square feet and are comprised of executive and administrative offices, warehousing and on-site manufacturing and distribution facilities.\r\n\r\nOur product lines include Andrea, Ardell, Body Drench, Checi, China Glaze, Clean + Easy, Clubman, EzFlow, Fright Night, Gena, GiGi, ibd, 'N Rage, ProLinc, SuperNail, Surgi-Care, Tres Flores, and Youthair to name a few. With over 60 brands, our niche products reach all segments of retail, beauty-supply, grocery, boutique and specialty markets in over 180 co

Job Description Job Title: Sanitation Manager Location: Rancho Dominguez, CA Department: Operations Reports To: Plant Manager Direct Reports: Sanitation Workers Pay Range: $85,000 – $100,000 annually (DOE) Santa Monica Seafood Company is a leader in the seafood industry, known for our commitment to quality, food safety, and sustainability. Our Rancho Dominguez facility plays a critical role in delivering fresh, high-quality products to our customers. We are looking for an experienced Sanitation Manager to lead our sanitation team and ensure our plant operates at the highest levels of cleanliness, safety, and compliance. Position Summary The Sanitation Manager is responsible for planning, coordinating, and directing sanitation activities to ensure the facility meets all regulatory, customer, and company standards for cleanliness, hygiene, and food safety. This position manages sanitation workers, oversees cleaning schedules, and works closely with Quality Assurance, Maintenance, and Production to maintain a safe and compliant processing environment. Key Responsibilities * Lead, supervise, and develop the sanitation team to ensure effective cleaning of equipment, processing areas, and plant facilities. * Develop and maintain sanitation schedules, procedures, and documentation to meet FDA, USDA, HACCP, and third-party audit requirements. * Ensue compliance with GMPs, SSOPs, and company food safety programs. * Inspect and audit sanitation processes and verify effectiveness through ATP swabs, microbial testing, and visual inspections. * Manage sanitation chemical usage and inventory; ensure safe handling and training for all sanitation employees. * Collaborate with Production, Maintenance, and QA teams to address sanitation-related issues. * Train sanitation staff on safe work practices, chemical handling, and cleaning procedures. * Maintain accurate sanitation records for audits and regulatory compliance. * Participate in food safety and quality improvement initiatives. * Troubleshoot and resolve sanitation-related equipment and process issues. * Ensure sanitation activities are completed efficiently while minimizing downtime. Qualifications * Required: Minimum 5 years of sanitation experience in a food manufacturing or seafood processing environment, with at least 2 years in a supervisory or managerial role. * Strong knowledge of GMPs, HACCP, SSOPs, and food safety regulatory requirements. * Experience preparing for and passing third-party and regulatory audits. * Proficient in sanitation chemicals, equipment, and safety protocols. * Strong leadership, communication, and problem-solving skills. * Ability to work in a fast-paced manufacturing environment and handle multiple priorities. * Bilingual English/Spanish preferred. Physical Requirements * Ability to stand, walk, bend, and reach for extended periods. * Ability to lift and carry up to 50 pounds. * Work in cold and wet environments (34–40°ree;F) for prolonged periods. * Wear appropriate personal protective equipment (PPE) as required. * Climb ladders and access elevated areas as needed. Work Environment * This position operates primarily in a refrigerated food processing plant. * Exposure to wet and humid conditions, strong cleaning chemicals, and varying temperatures. * Work may include evenings, weekends, and holidays as needed to meet sanitation schedules. Santa Monica Seafood Company is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Company DescriptionSanta Monica Seafood, established in 1939, is the largest seafood-only distributor in the Southwestern United States. With a commitment to quality, sustainability, and food safety, we serve a diverse clientele across the nation. Our Rancho Dominguez facility is a state-of-the-art 120,000 sq. ft. headquarters dedicated to processing and distributing premium seafood productsSanta Monica Seafood, established in 1939, is the largest seafood-only distributor in the Southwestern United States. With a commitment to quality, sustainability, and food safety, we serve a diverse clientele across the nation. Our Rancho Dominguez facility is a state-of-the-art 120,000 sq. ft. headquarters dedicated to processing and distributing premium seafood products

Job Description General Position Summary The Senior Scientist has an overall responsibility for reagent and product development following design control guidelines to meet Food and Drug Administration (FDA) and the in-vitro medical devices Regulation (IVDR) regulatory requirements. The incumbent is responsible for developing and improving reagents and assays for automated and manual immunohistochemistry (IHC) and in situ hybridization (ISH) staining and in other areas as assigned. Essential Job Functions Research and Development Activities • Develop quality reagents and IHC or ISH staining protocols to meet the demands of Sakura's global IHC and ISH market., • Develop new antibodies, probes, and IHC/ISH detection reagents to expand the reagent lines, documenting appropriate specificity/sensitivity, precision, robustness, and stability as required., • Continually monitor productivity and quality and make improvements., • Facilitate technology and reagent development process transfers., • Support program directives from senior management., • Perform microscopic interpretation of stained slides., • Work with the project manager and team to develop and launch new products., • Ensure compliance with all applicable environmental, health, and safety regulations., • Develop, plan, and implement product and process development for new products and technologies from the laboratory through manufacturing scale-up., • Provide technical expertise for all Reagent Product/Process Development activities., • Participate as needed in project teams, task forces, and business or technical meetings., • Provide technical advice to internal and external customers., • Support products from early development, finalization, manufacturing, and launch., • Write and file patent applications as warranted., • Capable of working with external collaborators on complex scientific projects., • Present scientific research findings or new technology in scientific meetings and workshops., • Ensure that Sakura's Quality System is deployed and actively seek continuous improvement opportunities., • Adhere to Good Laboratory Practice (GLP) and support any activity that is needed for FDA and IVDR compliance and/or ISO certification., • Follow up on R&D action items addressed by different teams and assist in resolving quality issues., • Implement preventive action based on improvement opportunities or trends identified during Leadership Review meetings., • Initiate action items and assign responsibilities. Education • Ph.D. or master’s degree or equivalent in a relevant scientific discipline., • Experience in tissue histology or pathology., • Minimum of five years of laboratory experience, including independent experimental design, data collection, interpretation, and report writing., • Must have demonstrated expertise with histology and anatomic pathology methods, including IHC/ISH staining and microscopic interpretation of stained slides., • Must possess essential knowledge of immunochemistry, histology, and molecular biology methods., • Must be proficient in immunohistochemistry and in-situ hybridization methodologies on formalin-fixed, paraffin-embedded human tissues such as antibody development/characteristic/production, immunohistochemistry detection system, and antibody conjugations., • Must be able to troubleshoot assay performance issues independently., • Practical experience with light and fluorescence microscopy, ideally including proficiency in whole slide scanning. Requires clear and concise verbal and written communication skills, strong technical writing abilities, and the capacity to present complex technical information in an easily understandable manner. Proficient computer skills, including Excel Spreadsheets, and PowerPoint., • Excellent analytical, organizational, and problem-solving abilities. Required skills include interpreting data, performing mathematical calculations, drawing informed conclusions, and creating and executing strategies and processes to achieve objectives. Proven capability to lead and coordinate teams to reach targets and assess the success of various programs and projects., • Track record of assay development and optimization, preferably in tissue- and slide-based settings., • Track record of establishing and maintaining collaborations with other departments and external organizations., • Laboratory work experience should include a thorough understanding of principles, theories, and practices of immunohistochemistry assay and cell/molecular biology., • Experience in DNA/RNA isolation from cells and tissues, sequencing, and designing nucleic acid probes and primers is a plus., • Hands-on experience with mammalian cell culture and bacterial culture, preferably including cytogenetic specimen preparation, is a plus., • Excellent interpersonal skills with the ability to analyze and weigh the opinions of experts in the field of biomarker detection., • Interact in a professional and proactive manner with internal and external customers., • Must be able to generate, interpret, and present technical data to meet customer requirements., • Must orchestrate the technical expertise of all team members in answering customer requirements., • This position requires the employee to sit and work in a laboratory setting frequently. In addition, the employee is occasionally required to stand, walk, use hands and fingers, and reach with hands and arms., • Must be able to lift, push and/or pullup to 50 pounds occasionally with assistance., • Ability to successfully respond to multiple work pressures. The above description identifies the essential job functions and skills needed by the person or persons assigned to this position. These job functions and skills are not intended to be a complete and exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the company's discretion.

Job Description Job Summary Create and maintain technical documents such as Specifications, Ingredient Statements, Allergens, Nutritional, Technical Letters, and SDS. Work with QC, R&D, and Production to coordinate appropriate information for the documents. Major Responsibilities • Create accurate technical documents as required by internal programs as well as per customer request on timely manner., • Maintain technical documents for updates, revisions, and regulatory requirements. Maintain vendor management program., • Provide technical support to the clients and internal Sales/Customer Service departments., • Create official communication to our clients in form of business letters., • Investigate specific technical information as required for documents or per requests., • Organize and maintain both electronic and hard copy raw data. Keep up to date with current industry news and upcoming new regulations., • B.S. in Food Science/Chemistry or related field., • Familiarity with FDA (21 CFR) and USDA Regulations., • Working knowledge of Word and Excel.

Job Description Job Details Shifts: Day Location: Anaheim, California Salary: $124,700-$135,000 per year/DOE Medical benefits-eligible first of the month following 28 days of employment. All other benefits-eligible first of the month following 90 days of employment. Benefits: 401(k) with generous Company match Dental insurance Health insurance Health Savings Account Flexible Spending Account Life insurance Paid time off Employee Referral Program Vision insurance Position Overview: The Quality Assurance Manager is responsible for all segments of the quality assurance and control function either directly or through Quality Assurance supervisor and staff. Responsible for the development of techniques and procedures for inspecting and testing customer’s products, and for the conducting of research on product defects in order to recommend modifications in products and/or quality standards on the basis of this research and of analysis of customer complaints. May also include responsibility for actual inspection and testing operations. Language Skills: English proficiency required. Spanish is a plus. Supervisory Responsibilities: Yes. Amount of Travel Involved: 10% Essential Duties and Responsibilities: • Follow all safety procedures and work as safe as possible at all times., • Direct the department performing timely execution of product and packaging evaluations., • Ensure that all the results of the inspections and analysis are accurate and timely., • Interpret any trends that may jeopardize product quality and safety., • Ensure that departmental, company, customer and regulatory guidelines are adhered to., • Ensure that customer requirements for obtaining line analysis reports and line samples are met., • Ensure that all products not meeting established specifications are held and segregated; sampled and appropriate documentation is generated., • Communicate and coordinate with the manufacturing departments to ensure a concerted and proactive team effort is maintained., • Direct the training of all associates and ensure that proper skill sets are developed and documented., • Ensure that equipment and reagents are being calibrated and labeled., • Establish sampling plans in the various steps of the following processes:, • Ingredient and packaging receiving., • Blending and thermal processing for product quality or if safety may be jeopardized., • Finished goods to ensure quality parameters are met., • Held product for further analysis and disposition., • Trouble-shoot and identify causes of quality deviations and provide recommendations for corrective and preventative measures., • Direct the implementation of Plant GMP, HACCP and Sanitation Inspections., • Oversee the Food Safety Team Leader and ensure that Food Safety Programs are implemented., • Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product., • Formulate and maintain quality control objectives complementary to corporate policies and goals., • Directs the creation and implementation of inspection criteria and procedures., • Coordinates objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs., • Applies total quality management tools and approaches to analytical and reporting processes., • Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products., • Creates and directs environmental test functions., • Plays active role on quality management teams within organization., • Designs and implements quality control training programs in conjunction with managers., • Investigates customer complaints regarding quality., • Oversees companywide adherence to our procedural documentation (quality management system) and its compliance with ISO., • Identify and implement Quality Department goals and objectives in support of companywide strategic business plans., • Serves as the primary interface with Quality Assurance Representative to encourage effective communication and good customer relations., • Creates and supports the management of budgets and staffing forecasts to facilitate successful execution of the department goals and support of all projects., • Manages the required training, process improvement activities, and the development and implementation of new systems affecting the Quality Department., • Facilitates the efforts to implement industry-wide/best practice standards., • Implements a rigorous continuous process improvement program with emphasis on Lean, cycle time reduction, elimination of rework/defects, and root cause analysis., • Maintains Quality metrics, and a management dashboard of those metrics, and assesses performance against project and enterprise goals., • Responsibility to act as the primary liaison with the FDA and other regulatory agencies, • Responsible for managing the process of fulfilling regulatory quality assurance and for providing guidance to the company with regard to quality assurance requirements, • Ensures all documentation meet required regulatory standards, • Serve as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement., • Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions., • Establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality., • Analyze customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility., • Develop quality planning methods for all product lines., • Develop process certification standards and assist in process certification., • Review customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans., • Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel., • Oversee calibration and testing programs., • Report to management on quality issues, trends and losses., • Participate in internal and external quality audits., • Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented., • Review of the Food Safety Management Systems to ensure its continuing implementation, suitability, adequacy, efficiency, and effectiveness, • Promotes customer focus and customer satisfaction throughout the organization by meeting customer requirements, addressing conformity of products and services risks., • Maintain a positive work atmosphere and interaction with customers, co-workers, and management., • Perform all other duties as assigned., • Regular and punctual attendance., • Excellent written and verbal communication skills with the ability to communicate professionally with customers and co-workers., • Have a strong work ethic and be able to work independently as well as work in a team., • Must have strong analytical and problem solving skills., • Demonstrates attention to detail, a professional attitude, and produces accurate work product., • Excellent organizational and time management skills., • Ability to prioritize, multi-task, and adhere to deadlines., • Must have a cooperative attitude., • Must have the ability to follow-up., • Bachelor of Science degree required in a food science related field; biology, microbiology, or chemistry, • Masters of Science preferred, • Minimum of 10 years in quality assurance/control management function, • Knowledgeable in cans, bottles and Aseptic Tetra Pak packaging is preferred, • Must be knowledgeable in pasteurization/thermal process systems, HACCP, and GMP programs, FSSC 22000 and ISO 9001:2015, Organic certification program, State pH Control program, Kosher inspections and third party GMP and Food Safety audits, • Must have working knowledge of product formulations and specifications, • Upholds mental, spiritual and physical safety, • Asks for and provides feedback, • Holds self and others accountable, • Supportive and collaborative of team members, • Participates in self-development and encourages the development of those who report/to him or her and peers While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands to finger, handle or feel and reach with hands and arms. The employee is occasionally required to stand; walk and stoop, kneel, crouch or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high places and outside weather conditions. The noise level in the work environment is usually loud. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals; extreme cold and extreme heat. The noise level in the work environment is usually very loud including but not limited to manufacturing equipment. Manna Beverages is an equal opportunity employer-----M/F/D/V

Job Description ORANGE COUNTRY / L.A. METRO - With more than 100 ecommerce searches each year, EcommerceRecruiter.com is the leading contingency-based recruiting firm serving the NRF, IR-1000, and B2B communities. To opt-in to our popular "Ecommerce Job of the Day" email, click here. One of the coolest ecommerce jobs around! HARRY'S COMMENTS: We are working with a profitable, growing, PE-backed skincare brand in its search for a Director of Ecommerce based in always-sunny Orange County / L.A. Metro. Founded by a world renowned dermatologist and pioneer in medical grade skin care, the client has established itself as a leader in the doctor-dispensed cosmeceutical market. The firm has 300 employees and operates with the scientific credibility that only comes from real medical expertise combined with the commercial sophistication of one of the world's best private equity investors. The client's unique value prop lies in its two-channel approach: It maintains professional distribution through more than 4000 authorized healthcare providers while also building a robust DTC ecom business. This hybrid model offers two self-reinforcing advantages: 1./ It provides credibility through professional endorsement, while 2./ connecting online sales to physician referrals. This, in turn, drives higher LTVs through the trust associated with medical recommendations. Not surprisingly, my client's product portfolio centers on medical-grade formulations that command premium AOVs thanks to the clinical backing that support their efficacy claims. Its products have demonstrated clinical results, enabling the company to maintain strong margins while commanding higher price points than traditional beauty products. Operationally, the brand is growing like a weed: A recent platform migration resulted in an increase in conversion rates and a decrease in bounce rates. Yet this is a complicated business, which accounts for the the emphasis on Salesforce Commerce Cloud in this job spec. More on that below. About the Industry The physician-dispensed cosmeceuticals market is one of the most attractive segments in thee beauty industry, combining the growth dynamics of skincare with the credibility and pricing power of medical authority. The global market is projected to reach $13.93 billion by 2030, growing at nearly a 8.8% CAGR, driven by increasing consumer demand for science-backed, clinically proven skincare products. This growth is occurring within the context of a massive $716 billion global beauty ecom market ... But unlike traditional beauty products, medical-grade skincare benefits from longer customer consideration periods, higher AOVs, better customer retention rates, and reduced price sensitivity. The competitive landscape includes established dermatologist-dispensed brands and emerging AI-powered personalization platforms. Broadly speaking, the industry is experiencing consolidation pressure as major beauty conglomerates like L'Oréal, Unilever, and P&G aggressively expand into medical-grade skincare through acquisitions and new product development. Several trends are reshaping the industry landscape: Customer acquisition costs in beauty ecommerce are increasing, with some DTC brands reporting 30%+ increases in paid media costs, making a well-run physician referral channel increasingly valuable. Meanwhile, the expansion of telemedicine creates new opportunities to blend physician expertise with DTC sales, while regulatory scrutiny of cosmeceuticals continues to intensify. Beyond that, beauty subscription models are growing as consumers seek convenient access to professional-grade products, creating recurring revenue opportunities essential for private equity valuations, while technology is becoming increasingly central to competitive differentiation. Beauty ecommerce trends emphasize AI-driven personalization and virtual diagnostic tools, areas where medical-grade companies can leverage their clinical foundation to develop sophisticated skin analysis capabilities that cosmetic brands cannot replicate. About the Role As my client's new Director of Ecommerce, you'll manage all the complexity that goes with scaling a $50 million P&L in a regulated, physician-dispensed market under private equity ownership. This role requires ... • an exceptional blend of technical platform expertise,, • strategic business acumen, and Salesforce Commerce Cloud mastery is essential, given that my client's business involves medical-grade skincare requiring sophisticated regulatory compliance, professional channel integration, and complex product configurations that consumer platforms cannot handle. Their $40M-$50M ecom P&L requirement means you'll need a proven ability to manage complex unit economics in competitive beauty markets while meeting institutional investor reporting standards. Sharpen your pencils! Moreover, you'll need to understand the mechanics of premium brand storytelling and know how to translate things like "clinical efficacy" into plain, simple language your customers understand. There's a fine line between maintaining medical credibility and appealing to your target customer's wants, needs, and desires. Don't forget: There are FDA restrictions on therapeutic claims, so you can't just "say anything" in an effort to build trust through scientific validation and professional endorsements. In this role, we are looking for someone with proven experience with conversion rate optimization, omnichannel analytics, and subscription based revenue models. Cross-functional leadership experience is a must, as is a working knowledge of Salesforce Commerce Cloud. Given that you'll have some involvement with private equity operating partners, financial literacy is essential. About the Compensation This is an on-site role, and the client offers relocation. This is not remote, so don't ask about it. (Sorry.) You can plan on this role maxing out at $165,000 base. Depending on where you live, that's a lot of money. If you live in New York, that will be like getting a (very) nice raise. If you live in Atlanta, let's just say you won't be taking this job for the money. You'll be taking it purely because it's an amazing gig. Which it totally is. Just to reinforce the point: This afternoon, I spent an hour on the phone with this role's hiring manager (your new boss), going back-and-forth about the actual cities where I should be recruiting for this position. Certainly New York is one of them. San Francisco is another. Seattle is another. Take a look at the following cost of living numbers I pulled up off of Perplexity.CitySingle PersonFamily of 4Rent (1BR, city center)Rent (2BR)Notable CommentaryNYC$6,389$10,338Not specifiedNot specifiedHighest cost for both singles & familiesSan Francisco$5,897$8,833$2,252Not specified3rd most expensive in the US; high housingLos Angeles$4,530$7,417$2,600High cost, but lower than NYC/SF/SeattleAtlanta$3,318$5,861$1,929Considerably more affordableChicago$2,180~$2,972Moderate to high, but below coastal cities What this Means It means that my target A-player for this position is a rising star who, up to this point in their career, has been entrusted with a lot of responsibility and is looking for an opportunity to live in a sunny climate, working with a smart as hell team, while doing a very high profile job that will get her noticed by a lot of important people. You'll have a ton of opportunity for personal and professional growth, which frankly is the right reason to take any great job. But I thought I would bring this up now because it's not uncommon for me to receive a ton of applications from great candidates to think that once my client meets them, they'll pay more. In this case, that's not likely to happen. I'm just being honest. If you've made it this far in the job posting, then you're obviously intrigued. While you're thinking about it, head over to YouTube and look at some drone footage of the beaches around LA County ... How awesome is that? You could live there! And if you are a rising star in the industry, it will be affordable. But if you have a big family, maybe not so much. You won't believe how much we know about this search ... I spent a ton of time on the phone with the client teasing out exactly what you’ll need to KNOW and DO to hit the ground running in this role. Some of the things I can share with highly qualified candidates include ... • The "real" background requirements for this position, along with the top five things all resumes MUST have to be considered for the role., • The top five problems that exist due to this position being open. These are the little brush fires you will be expected to put out during your first month on the job. Every ecommerce job has these — and this one's no different., • What your average day/week will look like in this role. There's what you read in the standard ecommerce job posting ... then there's reality. We've got the reality., • The leading and lagging KPIs that will determine your success in this role. In a nutshell: How you'll keep score., • The major projects you’ll need to complete by Day 100 to be considered a home-run in this position. We’ve got the lowdown on how you can plug-and-play and drive REAL value in this ecommerce job. I have a massive amount of proprietary intel to share with qualified candidates. My industry research for this assignment exceeds 100 pages! Be sure to TEXT me, Harry Joiner, at (404) 281-2025 for this info. Or simply use the email link when you apply for the role below. Essential Duties And Responsibilities eCommerce Operations • Execute the North American eCommerce strategy aligned with broader business goals and digital objectives, • Manage the direct-to-consumer digital business, ensuring consistent growth in awareness, engagement, and revenue, • Lead initiatives that improve the customer journey from discovery through conversion and retention, • Oversee eCommerce merchandising strategy, promotions, seasonal campaigns, inventory planning, content and analytics, • Build strong partnerships with internal stakeholders (Finance, Marketing, Product Development, Supply Chain, Customer Service) to ensure North American business achieves its goals, • Manage third-party agencies, system integration partners and vendors (developers, subscription platforms, CRO tools, etc.) Digital Execution • Manage and implement an ecommerce roadmap to drive revenue, profitability, and customer satisfaction, • Launch new capabilities with a focus on loyalty, personalization, and content, • Champion the customer experience by improving UX, streamlining journeys, and delivering personalized content, • Identify and integrate emerging digital capabilities to drive differentiation and engagement Data & Analytics • Provide weekly and monthly sales reporting with defined KPIs, • Surface actionable insights using customer surveys and digital analytics, • Test and refine site experiences to improve conversion and retention rates, • Track the ROI of digital investments with clear reporting on customer growth, engagement, and eCommerce performance Performance & Optimization • Use data and testing to identify friction points in the customer journey and prioritize improvements, • Collaborate with Finance to develop budget scenarios tied to sales goals and marketing investments, • Work closely with Planning teams to align inventory with demand, optimize assortments, and ensure product availability, • Provide regular reporting to senior leadership on DTC performance Qualifications • A Bachelor’s degree is required, preferably in a Marketing, Communication or related field; advanced degree preferred., • A minimum of 12 years of experience in eCommerce or digital marketing, preferably in beauty, skincare, or CPG is required, with a minimum of five years in a management role with DTC responsibility., • Proven success scaling an eCommerce business and achieving revenue targets., • Proficiency in Salesforce Commerce Cloud and analytics tools (Google Analytics, etc.)., • Experience with CRM/email marketing (Klaviyo), conversion rate optimization (CRO), and A/B testing platforms., • Strong understanding of digital advertising, SEO, and retention strategies., • Exceptional project management and communication skills., • Passion for skincare and understanding of the beauty consumer a plus. Additional Skills And Abilities Include • Adaptive, responsive individual able to thrive in an extremely fast-paced and dynamic work environment; handles pressures well; adjusts plans to meet changing needs., • A team player who works well with a variety of field-based sales groups, cross-functional teams, brand leadership, global and clinical/retail partners., • Excellent organizational, time and project management skills., • Stay updated with market trends and competitor activities., • Excellent communication and negotiation abilities., • Problem-solving and decision-making capabilities.

Job Description:\n\n Are you ready to join a Global Leader in the Freight Forwarding and Contract Logistics field, who knows their employees are their greatest strength? LOGISTEED-America is on a mission to deliver high-quality transportation and logistics services and help make the world a better place for generations to come. We are looking for a Director of CHB Compliance to join us on this mission. Have you handled commoditiy classifications, writing customs bonds, overseeing audits and have enjoyed 15 years of more in the field of freight forwarding or international logisitics? Then this role maybe a great next step! Location: Can be located at any of our following nation-wide offices: Monterey Park, CA; Fullerton, CA; Forest Park, GA; Elk Grove Village, IL; Mineola, NY; Seattle, WA WHO WE ARE: Founded in 1950, LOGISTEED-America is part of a global network of companies providing transportation and logistics services including ocean & air freight transport, contract logistics, customs brokerage, supply chain management, and more. Summary The Director of CHB Compliance reports to the LOGISTEED-America, Inc. VP of Corporate Administration. This position requires excellent leadership skills along with the ability to monitor and report the activities of all Import Brokerage compliance in the US, including all Participating Government Agencies involved in regulating the importation of freight. Responsibilities include Setting policies, procedures and direction for a compliant Import Customs regulatory compliance program, monitoring and enforcing compliance policy guidelines for reasonable care and paperless recordkeeping. Other key responsibilities include, but are not limited to the following:To lead and manage client compliance needs. Provide Compliance presentations both externally and internally. Develop a strong, knowledgeable, pro-active team environment with all LUS managers. Manage all import brokerage compliance programs at LUS and provide regulatory guidance, support and training to branches.Develop a culture of accountability to achieve improved results, minimizing risks and liabilities to LUS and its clients through strong regulatory and corporate policy compliance.Ensure that the branch offices are in full compliance with U.S. Customs regulations Qualities Ethical with sound business judgementPossesses a passion to help team members Strong customer relations Detail-orientedReliable, follows through on commitmentsStrong process and planning orientationGoal-oriented, task drivenEnjoys being part of a team as well as leading oneBalances team’s needs with goals of organizationOutstanding written, verbal, presentation and organization communication skills Essential Duties & Functional Responsibilities Required Required Knowledge Skills & Abilities The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Functions Provide internal regulatory support & guidance including but not limited to the following compliance areas: Brokerage Compliance Work DutiesPerforming tasks safely Ensuring area housekeeping requirements are metMeets attendance & punctuality standards – please remember that attendance at facility is required 99% of the time [TM1]Meet established procedures and productivity, safety and quality standards.Management Reporting: Keep the Corporate Licensee and the VP of Corporate Admin informed about important issues and with updated progress on important projects and tasks.Conducts internal staff meetings, one-on-one coaching, and handles approvals of staff time-off requests in the ADP portal.Provide FDA shadow audits by Compliance Analysts or Managers to improve FDA’s branch audit results.May act as the Compliance point of contact between sales, branches, & key client compliance staff as brokerage SME.Assist with filing Petition for Relief from penalties Monitor and Ensure LUS’ CBP Annual Permit Fee and Triennial Report Fees are Paid & Submitted TimelyMonitor/Review all CBP Penalties issued against LUS or its Clients and Assist with MitigationReview/Approve Post Summary Corrections, Protests, 520(d), 520(a)(4), Prior Disclosures, and Entry UnlocksIssue and Monitor Employee POANew Employee Reporting to CBP via ACE PortalACE Portal Management and ACE ReportsProviding Updates to the Branches as Regulations and Policies ChangeTechnical regulatory guidance for branches when requested. Classification research upon request for complicated items.Review and audit branch-validated powers of attorneys in CW1.Review and monitor post-entry work (PSC, protests, etc.) Upon submission for approval to LUS CHB Compliance prior to CBP filing.Review binding ruling requests from branches on behalf of IOR.Monitor and manage compliance of reconciliation entries.Conduct brokerage policy compliance audits of branches:Conduct quarterly policy compliance audits of branches by compiling entry reports, conducting off-site and on-site evaluations.Issue summary reports/recommendations, require branch CIP, conduct follow up assessments on CIP implementation, and publish annual scorecard results by branch.Review & update all brokerage policies and procedures.Provide FDA guidance & shadow audits to improve FDA’s onsite audit results.Act as compliance point of contact between sales, branches, & key client compliance staff.Manage classification projects for importers: Quote pricing and perform certification and updates of classification databases.Assist clients for compliance with FDA and PGA requirements.Join managers or sales on local sales appts as brokerage SME.Support LUS bonded CFS stations with customs compliance by reviewing critical compliance areas, such as:Review/recommend updates to CFS sop to prevent violations and assist the CFS manager in training CFS employeesAudit monthly internal LUS customs entries and external customs entry quantities v CFS package count quantity releasesAudit CFS employee reporting to comply with CFS regsThe Director of CHB Compliance is responsible for all Customs compliance matters. Therefore, licensed managers of each LUS branch must directly report compliance matters to the Director in accordance with LUS CHB Compliance policies.Manage all customs brokerage branches in full compliance with regulations of US Customs and other participating government agenciesEstablish professional working relationships with Customs, other Government agencies and all other entities involved to achieve excellent resultsMaintain comprehensive resource materials COMMUNICATIONSCommunicate both orally and in writing in a clear and concise manner.Facilitates team meetings effectively.Keeps team well informed of changes within the organization and operations.Effectively communicates relevant information to superiors.Resolves and/or escalates issues in a timely fashion.Responds/acts on upper management direction. EMPLOYEE ENGAGEMENTInspiring and motivating employees to perform at their best through positive encouragement and incentive initiatives SAFETYAbiding by all Federal. State, Local safety regulations and OSHA rules and LOGISTEED-America, Inc. safety practicesMaintain a safe and healthy work environment by establishing, following, and enforcing standards and procedures; complying with legal regulations and ensuring area housekeeping requirements are met FINANCE Escalate any Lost Costs or financial impact to management Non -Essential FunctionsPerform other duties as assigned Competencies Strategic ThinkingProblem Solving/AnalysisProject ManagementOrganized / ability to prioritizeCommunication ProficiencyPersonal Effectiveness/CredibilityMulti-tasking with conflicting priorities Supervisory Responsibility Responsible for supervision of direct reports including Compliance Manager and Compliance Analyst.Oversee the day-to-day operations of the compliance departmentEnsure a culture and work environment in line with the company’s core value of respectLead by exampleEnsure that all team members are looking for ways to systematize the business to increase efficiency Preferred Qualifications, Required Knowledge Skills & Abilities and Working Conditions Previous Work ExperienceMinimum of 15 years brokerage experienceStrong classification and regulatory knowledge Compliance policy development and auditing experience3 years supervisor/managerial experience Education and Certifications Bachelor’s degreeEquivalent work experience will be considered in-lieu of educationLicensed Customs broker Experience Requirements and Preferences Work well with individuals of different languages and culturesEffective decision making, sound judgment, and initiativeExcellent organization skillsExcellent verbal, written communication & presentation skillsUnderstanding of brokerage CTPAT minimum security criteria (MSC)Strong attention to detailAbility to understand any and all safety requirements and regulations (OSHA)Ability to make decisions in an objective mannerStrong written and verbal communication skillsOrganizational, people, and interviewing skillsConflict resolution skillsStaff management; requires flexibility and understanding that all staff may be required to perform duties outside their normal area of expertise to meet the mission and goal Ability to respond to situations in a prompt and professional mannerProven professional and sound judgment in the management of difficult and / or sensitive mattersProvide excellent customer service to internal and external customers Ability to work in multiple systems and ability to input and retrieve data are a mustMust be able to read, write and countIntermediate/Advanced Proficiency in Microsoft Office: Word & ExcelEnergetic and highly motivated to succeedProven strong business acumen Fluency in EnglishMust pass drug and criminal background check Additional Eligibility Qualifications Ability to read, analyze and interpret compliance regulations and requirementsAbility to respond effectively to time sensitive work orders Work Authorization/Security Clearance (if applicable) Must be legally authorized to work in the United States Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to stand, walk or sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, bend crouch or crawl; talk or hear; taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move objects up to 25 pounds, and occasionally lift and/or move up to 35 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Work Environment One hundred percent of work time will be spent in an office setting where the environment is climate controlled. LOGISTEED America, Inc. is an equal opportunity organization. We abide by all applicable equal opportunity laws and regulations. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. PAY TRANSPARENCY NONDISCRIMINATION PROVISION - The company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. Information is obtained as part of an employee’s essential job functions if: (1) access to compensation information is necessary to perform that function or another routinely assigned business task, or (2) the function or duties of the position include protecting and maintaining the privacy of employee personnel records, including compensation information. Nothing in this statement prevents LOGISTEED America, Inc. from disciplining, terminating, or otherwise taking adverse action against an applicant or employee because they have violated another workplace rule. LOGISTEED America, Inc. fully supports the above pay transparency nondiscrimination statement. EOE/M/F/D/V Pay Range: $160,000 - $200,000 - DOQ

Job DescriptionDescription: About the Company Shengsheng Supply Chain Management is an international logistics company that provides professional and integrated solutions for global time and temperature-sensitive cargo transportation. Professionally serving the life science, biotechnology and pharmaceutical research industries, supporting the international end-to-end transportation of clinical trial products, samples, commercial drugs, and biological and IVD reagents worldwide. The scope of services ranges from cold chain transportation, warehousing to customs clearance. At the same time, the technology in cold chain packaging has also been certified by most organizations around the world, and has been praised by thousands of partners and customers. Job Summary We are seeking an experienced and detail-oriented Licensed Customs Broker to lead and manage our import regulatory compliance processes. This role is critical in ensuring our shipments comply with all U.S. Customs and Partner Government Agencies (PGAs), including the DEA, USDA, FDA, CDC, and US Fish and Wildlife. The ideal candidate will possess a current U.S. Customs Broker License and bring expertise in customs documentation, classification, and communication with regulatory bodies. Main Job Duties: • Review and sign import documentation submitted to U.S. Customs and relevant PGAs (DEA, FDA, CDC, USDA, Fish & Wildlife) to ensure accuracy and compliance., • Serve as a resource to internal teams, clients, and partner offices by answering questions regarding U.S. import/export regulations., • Respond to external inquiries requesting authorization or clearance to ship goods to the United States., • Classify goods using the U.S. Harmonized Tariff Schedule (HTS) to determine applicable duties and ensure correct rating of shipments., • Liaise directly with U.S. Customs and Border Protection (CBP) and clients to resolve issues or facilitate smooth clearance., • Prepare, submit, and manage required documentation to various regulatory agencies in a timely manner., • Stay current with changes in customs regulations, trade laws, and agency policies, and proactively train and share knowledge with colleagues., • Maintain a strong understanding of internal SOPs and ensure all procedures are followed accurately., • Required: Valid U.S. Customs Broker License., • 3+ years of experience in customs brokerage, regulatory compliance, or international trade., • 3+ years of hands-on experience in managing FDA-regulated logistics, • Demonstrated knowledge of CBP procedures and regulations, including those of PGAs (DEA, USDA, FDA, CDC, USFWS)., • Strong working knowledge of HTS classification, customs documentation, and import clearance., • Excellent attention to detail and ability to manage multiple priorities., • Clear and professional communication skills – written and verbal., • Proficiency in Microsoft Office Suite and customs brokerage software (e.g., Descartes, WiseTech, or similar)., • Experience supporting life sciences, healthcare logistics, or regulated industries., • Familiarity with ACE, ABI, and PGA message sets., • Bilingual capabilities a plus (especially Mandarin or Spanish)., • Strong problem-solving skills and a collaborative mindset.

Job Description Technical Writer Do you want to be part of an organization on the cutting edge of technology? We're looking for talented people to join our motivated and friendly team. We have an open, collaborative, and flexible environment. You'll work alongside leading industry experts and take on challenging projects that bring tomorrow's electronics to life. If you want to make a difference, are an effective communicator, love a good challenge, and easily embrace change, your next career adventure awaits! Mycronic is a global high-tech company whose innovative solutions have been advancing electronics technology for over 40 years. Today we continue to grow and serve customers in an expanding variety of industries. What we do impacts the future of technology, and in turn, the way we live our lives tomorrow. Position Overview We are looking for an experienced Technical Writer to join Mycronic's Global Technologies division working within our Applied Plasma business line (Surfx Technologies). It is an exciting time to join our team! Surfx Technologies is a fast-growing company that offers atmospheric argon plasmas for the high-volume manufacturing of integrated circuits, semiconductor packages, printed circuit boards, and other microelectronic devices. These automated plasma machines are an excellent choice for surface cleaning, activation, and metal oxide removal. The Surfx team delivers this atmospheric argon plasma technology for assembled products that are less likely to corrode, delaminate, or come unglued during their lifetime. Our customers include the world's leading semiconductor manufacturers and technology companies. The Technical Writer at Surfx Technologies plays a critical role in supporting the Atomflo plasma platform and related products by producing clear, accurate, and user-friendly documentation. This role ensures that internal teams and external customers have access to high-quality materials that facilitate product understanding, integration, and troubleshooting. The Technical Writer collaborates cross-functionally with engineering, software, production, and quality teams to translate complex technical concepts into accessible content. This position contributes directly to product success by maintaining documentation standards, ensuring regulatory compliance, and enhancing the overall user experience. Key Responsibilities • Develops and maintains technical documentation for Surfx Technologies' Atomflo plasma system and associated products, including user and service manuals, integration and installation guides, software release notes, standard operating procedures (SOP's), troubleshooting and maintenance instructions, • Collaborates with subject matter experts (SMEs) across engineering, software, and production teams to gather accurate and up-to-date information, • Standardizes documentation formats to align with industry and customer expectations, including SEMI, ISO, and FDA standards when applicable, • Ensures documentation compliance by working closely with quality and regulatory teams, • Manages version control and maintain consistency across all technical publications using tools such as Git, SharePoint, or other document management systems, • Collects and incorporates feedback from internal stakeholders and customers to improve clarity, usability, and completeness of documentation, • Bachelor's degree in Technical Communication, Engineering, English, or a related field; equivalent experience will also be considered, • 5+ years related experience required, • Proven experience creating technical documentation for hardware/software systems, preferably in manufacturing or high-tech environments, • Strong ability to translate engineering concepts into clear, concise, and accessible content for both technical and non-technical audiences, • Proficiency with documentation tools such as MS Word, Adobe FrameMaker, Confluence, MadCap Flare, or similar authoring environments, • Familiarity with version control systems and document management platforms, • Exceptional written communication skills and attention to detail, • Strong organizational and project-management capabilities, with the ability to manage multiple documentation projects simultaneously The physical demands and working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Standard office environment. Significant computer work should be expected. A Culture of Collaboration & Personal Growth At Mycronic, we love what we do, but most importantly who we do it with. Because to us the relationships we have with our customers and each other are the keys to success. Take part in the excitement of working with innovative people and global businesses who are elevating today's standards in modern electronics. Share in the responsibility of bringing great ideas to life within an inclusive culture that not only promotes personal growth and embraces diversity but depends upon it. Here you are expected to have a voice and will be encouraged to get involved. It's this very mindset that empowers our people to make a positive difference for a broad range of businesses, society and the planet – every day. Click to learn more about Mycronic and what it's like to work with us Equal Opportunity Employer Mycronic is an equal opportunity employer committed to workplace diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. For a company founded on passion, collaboration and outside-the-box thinking, there is no greater asset than a diverse workforce. It is the cornerstone of our global, internal culture, and we actively promote an inclusive and healthy work environment by embracing diversity and showing compassion for our colleagues. Not only does it fuel our innovation capabilities, but it also deepens our understanding of our customers as well as the different cultures in which we operate. We believe quite simply that diversity is our competitive edge. Job Posted by ApplicantPro

Job DescriptionDescription: The Sr. Quality Manager is responsible for leading and managing the development, implementation and continual improvement of Quality Assurance and Quality Control functions for the manufacturing site. This position will ensure that Hyland’s products conform to company standards, GMP and regulatory requirements. This position will provide support, direction and coaching across the organization in collaboration with internal teams. Essential Duties and Responsibilities include the following: • Manages Quality functions (such as quality technicians, quality inspectors, product release, quality control, document control, and training) to provide needed support for manufacturing operations to ensure GMP compliance., • The position has the GMP decision making authority over manufacturing processes, review and approval documents throughout the manufacturing processes, and Quality System documentation (deviations, investigations, change controls, etc.)., • Manages incoming inspection of components and testing of raw materials as well as release in accordance with established requirements., • Ensures appropriate review and approval of Master Batch records, change control documentations, packaging and labeling documents, audit observations, product specifications, and analytical methods., • Provides guidance to navigate rejected materials and appropriate investigations., • Manages batch record issuance, batch record review, and product release processes at Hyland’s facility., • Ensures that all deviations, including laboratory out-of-specification results occurring during manufacturing are investigated appropriately to ensure that necessary Corrective and Preventive actions are implemented., • Reviews Change Controls to ensure proposed changes are justified, evaluated, and implemented to meet GMP requirements., • Oversees Document Control function and SOP lifecycle management., • Oversees Training Program to ensure all GMP employees have training plans based on job function which includes annual GMP training., • Leads QC lab in compliance with regulatory requirements (GLP, USP, data integrity, etc.). Responsible for accuracy integrity of laboratory data., • Overseas Deviation / CAPA program to ensure thorough investigations, product impact assessment, identification of the root cause and implementation of corrective action to mitigate recurrence., • Support plant validation and qualification projects., • Review internal quality KPIs and identify opportunities for improvements. Support compilation of bi-annual QMR data., • Lead and participate in process improvement initiatives., • Sustain Facility Walkthrough Program and oversee completion of resolutions to maintain plant inspection readiness., • Work independently and ensure that documents tied to product release are prioritized., • Perform all responsibilities in accordance with company guidelines, Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, and regulations., • Responsible for ensuring adequate resources/staff to maintain business continuity, assigning work, meeting deadlines, interpreting, and ensuring compliance to procedures., • Responsible for communicating and/or facilitating personnel actions; including but not limited to hiring, termination, salary and performance reviews, disciplinary action, approving paid time off, overtime, etc., • May be required to perform other duties as assigned or as needed. Supervisory Responsibilities: This position will have responsibility of managing a select number of direct reports. Reports To: Director of Quality Requirements: Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience • Bachelor’s or advanced degree in scientific field., • 10+ years of experience in GMP regulated industry including 7+ years in Quality organization with 3+ years in Quality Management. Knowledge, Skills, and Abilities • In-depth knowledge of cGMPs, FDA and ICH guidelines/regulations (pertaining to OTC, Dietary Supplements, Food, Cosmetics) and guidelines., • Ability to apply an understanding of manufacturing processes, testing requirements, component/raw material inspections, raw material/product releases to documents related to products., • Demonstrate problem solving ability to lead problem solving teams., • Strong interpersonal skills to positively and professionally interact with colleagues and work in a team-oriented environment; be able to influence and engage at all levels of the organization., • Demonstrate strong technical ability and skills in product, process and/or testing knowledge., • Demonstrates attention to detail, and able to recognize critical attributes, steps and functions relating to manufacturing processes and/or laboratory activities., • Superior organizational skill: ability to prioritize and manage multiple time-sensitive tasks as defined and expected., • Attention to detail and ability to maintain consistency., • Ability to lead and motivate teams., • Strong verbal and written communication skills., • Working knowledge of PC technology (i.e., Outlook, Excel, Word, PowerPoint, Internet, etc.) and knowledge of Quality Management Systems. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk and hear. The employee is occasionally required to stand, walk; use hands to finger, handle, or feel and reach with hands and arms. The employee may occasionally lift/move up to 10 pounds. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. This job description is subject to change at any time.

Job DescriptionJob Summary: The Process Engineering Chemist I is responsible for performing a range of duties. You will play a crucial part in optimizing manufacturing processes to enhance efficiency, quality, and productivity. This role requires a blend of technical skills and innovative thinking, as you will work closely with engineers to implement improvements, troubleshoot issues, and ensure that all procedures comply with industry standards. Location: Onsite Torrance, California Salary Range: $45,000.00 - $55,000.00 Responsibilities: • Making lab batches /validations, • Assist in the development of manufacturing processes., • Preparing project raw material/ and inventory., • Monitor and analyze process performance data., • Support the implementation of new production equipment and technologies., • Perform routine maintenance and calibration of process control systems., • Preferred Degree in Chemistry or Chemical Engineering or a related field., • Problem-solving and analytical skills., • Strong communication and teamwork abilities., • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)., • Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance., • Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts., • Good understanding of safety protocols and practices., • Strong attention to detail and organizational skills., • Ability to work independently and as part of a team., • Effective verbal and written communication skills., • Willingness to work flexible hours, including shifts and weekends. Powered by JazzHR Gkm0MkIrSL

Job DescriptionBenefits: • 401(k), • 401(k) matching, • Competitive salary, • Dental insurance, • Health insurance, • Paid time off Orso Health is a leading organization in clinical research, dedicated to advancing healthcare through innovative studies. We operate across California and the Arizona markets and are known for our high standards of excellence and commitment to compassionate, patient-centered care for both pediatric and adult patients. Our dedicated team strives to improve lives through the expert diagnosis and treatment of a wide range of allergy and asthma conditions. We are looking for high-energy, kind, and collaborative individuals who are eager to grow personally and professionally to join our team. We are seeking a detail-oriented and proactive Administrative Assistant, Clinical Research to join our dynamic team. This role provides essential clerical and administrative support to our leadership, clinical providers, and research staff in a fast-paced clinical research environment. The ideal candidate will help ensure smooth daily operations and contribute to the successful coordination and execution of research studies. Responsibilities include organizing and maintaining research data and records, supporting regulatory compliance, managing study logistics, and assisting with patient and community engagement activities. Key Responsibilities Regulatory & Compliance Support: • Maintain up-to-date Investigator Site Files (ISFs) and regulatory binders (paper and eRegulatory), • Assist with study start-up, including IRB submissions and sponsor communications, • Track and manage essential documents (e.g., CVs, licenses, 1572s, financial disclosures), • Monitor document expirations and renewals (e.g., training records, IRB approvals), • Support audit and inspection readiness for sponsor and regulatory bodiesPatient & Community Engagement:, • Help coordinate patient recruitment and outreach efforts, • Manage patient appointment scheduling and pre-screening surveys, • Assist in organizing community education and screening events, • Track patient engagement and communication metricsAdministrative Support:, • Coordinate internal team meetings and manage supply inventory, • Draft and distribute meeting minutes, • Serve as a liaison between staff, patients, sponsors, and vendors, • Support Clinical Research Coordinators and leadership on special projectsQualifications & Requirements Education: • High school diploma or GED required; associate or bachelors degree preferredExperience:, • Minimum 1 year of experience in a medical, administrative, or clinical research setting, • Familiarity with FDA regulations, HIPAA, and ICH-GCP guidelines preferredCertification:, • Certification in medical administration or clinical research is a plusSkills & Abilities:, • Excellent organizational skills and attention to detail, • Strong communication and interpersonal skills, • Ability to multitask and manage shifting priorities independently, • Proficiency in Microsoft Office (Word, Excel, Outlook, Teams) and cloud-based platformsBenefits, • Competitive hourly compensation: $20.00$27.00/hour, • Health, dental, and vision insurance, • 401(k) with employer match, • Paid time off, sick leave, floating holidays, and holiday pay, • Time-and-a-half for overtime, • Professional development and continuing education support, • Hybrid/remote work flexibility with travel to clinical sites as neededSchedule & Location, • Full-Time: Monday to Friday, 8:00 AM 5:00 PM, • Hybrid/Remote role based in Los Angeles, CA, • Multi-site coordination with occasional local travel required