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About the Role Seeks an experienced Validation Tester to execute CFR Part 11 compliance testing supporting FDA approval processes for key pharmaceutical clients including Vertex. This hybrid position requires proven life sciences validation experience with immediate availability to begin certification work across multiple systems. Key Responsibilities · Execute validation testing for electronic records systems per §11.10 (accuracy, audit trails, data integrity) · Validate electronic signature functionality per §11.50 and §11.70 (authentication, non-repudiation) · Support FDA approval process through comprehensive CFR Part 11 certification across identified systems · Develop and execute IQ/OQ/PQ protocols and validation documentation · Create and maintain validation master plans, requirements traceability matrices (RTM) · Conduct risk-based validation and testing · Maintain FDA inspection-ready documentation packages · Collaborate with QA leadership to define validation roadmap and system requirements · Manage defect tracking with CAPA processes for critical issues · Test audit trail requirements Required Qualifications · 5+ years hands-on experience in pharmaceutical, medical device, or life sciences QA · Proven track record with 21 CFR Part 11 compliance validation and Computer Systems Validation (CSV) · Deep understanding of FDA regulations, GxP requirements, and data integrity · Experience supporting FDA approval processes and regulatory submissions · Experience with test management tools (Jira, TestRail, qTest, Xray, Zephyr) · Proficiency in validation documentation (IQ/OQ/PQ, VMP, RTM, URS/FDS) · Bachelor's degree in Life Sciences, Computer Science, or related field · Immediate availability to begin engagement Preferred Qualifications · ISTQB, CSQE, or CSTE certification · Automation experience (Selenium, Tosca, UFT) · CI/CD platforms knowledge (Jenkins, Azure DevOps) · Six Sigma or PMP certification · Experience with AI-powered testing tools and frameworks

Job Description Overview Prepares technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. Plays an integral role in the inventory and quality assurance activities. Schedule: Monday - Friday 9:00am - 5:30pm with weekend rotations • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Coordinates and facilitates new referrals and admissions through collaboration with nurses, customer service and distribution, • Conducts and documents initial and ongoing assessment of specific patient, drug and disease information to identify real and potential drug-related problems or needs, • Escalates to a clinician as needed, • Answers inquiries from patients, families, physicians and other healthcare professionals. Escalates to a clinician as needed, • Maintains thorough and appropriate documentation in the customer/patient record of all clinical activities and communication with patients, physicians and other healthcare professionals, • Coordinates and schedules the preparation of IV therapies and home medical equipment orders with the assistance of the Pharmacist, • Helps coordinate patient care activities with Pharmacists, Nurses, other Technicians and Patient Care Coordinators, • Prepares labels, prescriptions and compounding/mixing worksheets and completes and maintains product lot numbers, expiration dates and batch records, • Generates delivery/pick slips under the supervision of the Pharmacist. Picks and pulls supplies and home medical equipment, • Obtains supply inventories from patients/clients and communicates information obtained to the Pharmacist as required and documents all communication in patient progress notes on the pharmacy computer system, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations and standards relevant to infusion pharmacy and home medical equipment, • Other duties as assigned, • Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited pharmacy technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • One to three (1-3) years of related pharmacy experience in a home care setting, retail, or pharmacy setting, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately, and efficiently, • Valid driver’s license, preferred Driving Position: Yes To perform this role will require constant sitting and typing on a keyboard with fingers, and occasional standing, and walking. The physical requirements will be the ability to push/pull and lift/carry 10-30 lbs

Job Description Overview Amerita, Inc. is a leading provider in home Infusion therapy. We are looking for a Pharmacy Technician - Compounding to join our Pharmacy team as we grow to be one of the top home infusion providers in the country. The Pharmacy Technician will report to the Pharmacy Manager and work in our City, State branch. Amerita is an entrepreneurial-founded company and a wholly owned subsidiary of PharMerica. The home infusion market is positioned for rapid growth driven by the aging population, increase in chronic diseases, robust pipeline of infusible drugs coming to market, and an industry shift from hospital delivery settings to lower-cost, high-quality alternative providers such as Amerita. As a core member of the Pharmacy team, you will be expected to prepare technical and clerical tasks associated with the preparation, labeling and dispensing of pharmaceuticals. We will help you achieve your goals through continuous professional development and regular career progression discussions. Schedule: Monday - Friday 8:00am - 6:30pm with rotating Saturday • Competitive Pay, • Health, Dental, Vision & Life Insurance, • Company-Paid Short & Long-Term Disability, • Flexible Schedules & Paid Time Off, • Tuition Reimbursement, • Employee Discount Program & DailyPay, • 401k, • Pet Insurance Responsibilities • Coordinates and schedules the preparation of sterile mixtures and home medical equipment orders with the assistance of the Pharmacist, • Completes all calculations on product preparation as necessary, • Compounds sterile mixtures and non-mixtures, including, but not limited to parenteral nutrition, antibiotics, chemotherapy, hydration and narcotic analgesics, using aseptic technique where state laws permit, • Ensures compounding/clean room areas and related equipment are cleaned, sanitized and maintained in compliance with company policies and procedures, and USP 797 and USP 800 standards, • Documents all activities on appropriate logs, • Participates in branch management, department and intra-departmental meetings and quality improvement activities, • Adheres to all accreditation, OSHA, FDA, state, local and federal regulations, and USP 797 and USP 800 standards relevant to infusion pharmacy and home medical equipment, • Documents all temperature logs, pressure and humidity monitors, records all sterility testing done in the clean room in compliance with company policies and procedures, and USP 797 and USP 800 standards, • Documents all activities on the appropriate logs, • Other duties as assigned Supervisory Responsibility: No Qualifications • Successful completion of an approved/accredited Pharmacy Technician training program; IV certification preferred, • Registered Pharmacy Technician license in state of practice per state regulations, • National Pharmacy Technician Certification as required by the state board of pharmacy in state of practice, • 1-3 years of related pharmacy experience in a home care setting, retail or pharmacy setting, preferred, • At least 1 year of aseptic preparation of infusion-related pharmaceuticals in a hospital or home infusion setting preferred, • General knowledge of drug terminology, pharmaceutical calculations, drug use and aseptic techniques, • Flexible schedule with the ability to work on-call evenings and weekends on an as-scheduled basis, • Effective mathematical and communication skills required, • Basic pharmacy knowledge of reading and interpreting prescriptions, • Ability to work independently, accurately and efficiently, • Valid driver's license Driving Position: Yes-Minimal driving for patient deliveries may be required To perform this role will require constant sitting and typing on a keyboard with fingers, and ocassionally standing and walking. The physical requirements will be the ability to push/pull and lift/carry 21-30 lbs

Job Description Job Title: Material Handler The hours would be 9 am to 5:45 pm Job Purpose: The primary responsibility of this position is to transport assigned operational components, supplies and materials to requesting departments as well as transport full pallets of finished goods to storage and staging areas, loading and unloading trailer for delivery with a power and pallet jacks in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient flow of product through the production process. Individual will complete SAP needed transactions to request components for production and perform inventory adjustments. Major Accountability: Possesses required knowledge of SOPs, cGMPs, procedures, SAP entries and has the ability to explain the requirements to others as needed. Independently utilizes required Personal Protective Equipment and Safety Gear and performs a safety check on equipment to be used in the daily operations and ensure that all safety devices are functioning properly. Responsible for the movement of WIP materials within the warehouse. Communicates with Lead Operators and Management to maintain an efficient flow of material through the production process. Checks Compounding and Production schedules for batches to be run, transports materials and supplies to point of use staging area with the appropriate PIT equipment Responsible for the activities associated with the processing of finished goods for outbound deliveries. Keeps assigned areas clear and clean and transports unused components back to storage as required. Performs SAP inventory transactions, as required, to keep WIP inventory and Bin locations accurate. Responsible for overall housekeeping and organization of WIP Warehouse, including cycle counting, reconciliation and material destructions. Cleanliness of pallets/material containers, ensuring cleanliness and good condition of materials delivered to manufacturing. Also, maintain overall housekeeping of Production Staging Areas in Packaging, including cycle counting and reconciliation. At the end of shift, secure all equipment, perform general housekeeping duties and accurately complete all required paperwork. Performs other duties as assigned Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.) Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHAs HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA. Key Performance Indicators: Participate in Behavioural Based Safety Program (BBSP) by complying with all safety procedures and preventive measures (i.e., wearing Personal Protective Equipment (PPE), following lockout/tagout procedures). Ability to work independently and as part of a team in a fast in a fast-paced environment to meet the departments daily productivity and replenishment requirements. Demonstrated ability to manage multiple tasks simultaneously and be able to react to shifting priorities to meet business needs Demonstrated technical skills and knowledge of warehouse processing Strong team player; open to assisting with any task in order to get the work completed Quick learner; able to establish rapport and develop relationships Must be able to identify and recommend improvements. Ability to learn and apply new software multimedia applications Ability to lift up to 50 lbs. Ability to stand for extended periods of time Education/ Experience/ Background: Education: High School diploma or equivalent Languages: Fluent in written and spoken English Experience: 4 years of related experience

Job Description Position Description: Seeking a motivated, intelligent and hard-working individual to Develop and maintain quality and regulatory compliance in Genadynes' processes. Individual will ensure compliance with ISO 13485 and MDSAP requirements are maintained. Specific Responsibilities : Ensure the quality and processes are practiced and maintained. Compile documents required for audits. Create and maintain product technical files. Initiate corrective and preventive actions for non-conformities. Maintain/calibrate the accuracy of all testing equipment. Conduct risk assessments of medical devices and processes. Maintaining the effectiveness of quality control system and non-conforming materials control system. Discuss and solve quality problems with vendors. Investigate problems and make improvement on current processes. Develop/design effective test methods. Facilitate software design and development for medical devices. Performance testing and reporting on software, hardware and the compatibility for all accessories. Perform risk assessments for medical devices and accessories. Development and prototyping of new products with existing or new vendors. Abilities: Familiar with FDA CFR 820, ISO 134850, SOPs regulations. Extreme attention to details. Ability to think outside the box with excellent problem solving abilities. Excellent interpersonal, communication, and writing skills. Highly organized. Excellent computational skills. Knowledge of European regulations is a plus. Knowledge of common medical materials (silicone, polyurethane, etc.) Knowledge of electrical circuits and basic programming. Knowledge of C/C++ is a plus. Maintain MDD/MDR EN ISO Experiences: Regulatory compliance. Quality management. Cross functional team management. Quality assurance Requirements: Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field. (Master degree preferred.) Benefits: Medical, Dental, Vision, PTO, 401K, Legal Services, FSA, Life Insurance Salary Range: $68,000 - $72,000/Annual Powered by JazzHR oSPuR7OKHc

Job Description 3rd Shift in the Compounding department 10 p.m. through 6:45 a.m. (Monday through Friday), Pharma Operator - Assistant Job Purpose Assist in the compounding and mixing of Pharmaceutical bulk product. Perform other required departmental duties as required, i.e. cleaning, sanitization, etc. Major Accountabilities Following set Manufacturing Instructions, SOPs and GMPs, assists compounders in tending mixing tanks, compounding kettles, various mills and mixers, pumps etc. that mix, compound and mill raw materials used in the manufacture of pharmaceutical products. Transfer raw materials from staging areas or compounding areas. Transfers bulk product from compounding to storage areas. Assists in weighing out specified types and quantities of liquid or solid raw ingredients via automated dispensing systems or manual scales, according to formula. Transfers completed batches via pump or gravity drop into proper containers for movement to storage or other production departments. Proactively questions anomalies and utilizes opportunity for additional understanding of problem resolution. Extracts bulk samples for laboratory analysis. May assist in the handling, dispensing and sampling of hazardous raw materials. Assists in the daily cleaning/sanitization of kettles, mixers, pumps, utensils and compounding rooms. Performs daily environmental monitoring according to schedule and SOP. May assist in the weighing/mixing of sanitizing agents. Completes required batch documentation records. Assembles and disassembles pumps, mills, kettles, etc. Adheres to all applicable procedures, cGMPs, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals. Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHAs HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA. To perform this job successfully, an individual must have satisfactory visual acuity and peripheral vision. Visual acuity and peripheral vision screenings may be used to screen applicants. Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected. Satisfactory peripheral vision means a horizontal field of vision of at least 70 in horizontal meridian in each eye. Key Performance Indicators Manufacture according to Batch Right the First Time (BRFT) by supporting reduction in rejection of batches. Participate in Behavioral Based Safety Program (BBSP) by complying with all safety procedures and preventive measures (i.e., wearing Personal Protective Equipment (PPE), following lockout/tagout procedures). Follow proper documentation procedures. Job Dimensions Number of associates: N/A Impact on the organization: Critical, Limited Access Manufacturing Area Ideal Background: Related Pharmaceutical experience with Chemical background Education : High School Diploma or GED. Associates Degree preferred. Experience: Minimum 1 year experience working with chemicals in cGMP environment Proficiency in a Dispensary environment, or equivalent Solid English reading/comprehension skills required to understand detailed SOP, formula and Manufacturing Instructions Basic mathematical skills. Working knowledge of Metric System. Ability to comprehend cGMPs & SOPs and identify compliance or non-compliance with same Ability to lift 50 lbs. and to wear and properly use a half or full-face respirator May be required to work in full body protective wear for sustained periods while handling Hazardous materials Ability to maintain a high level of physical activity. Compounding is a restricted area with a high emphasis on cleaning and sanitary practices.

Job Description ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients' lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve. WHY JOIN OUR FAST-GROWING TEAM At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team! ESSENTIAL JOB FUNCTIONS The Inspire Territory Manager will lead commercialization activities introducing Obstructive Sleep Apnea (OSA) therapy to assigned sales territory. Performance objectives will include achieving sales plan and therapy awareness milestones. Assess new potential accounts within assigned sales territory. #LI-Remote OPPORTUNITIES YOU WILL HAVE IN THIS ROLE • A solid understanding of OSA technology as well as device implantation and follow-up procedures., • Drives implant growth to achieve sales plan through prompt account activation and efficient patient throughput., • Orchestrates commercial site assessment, selection, and development., • Achieves and exceeds assigned sales quota., • Ensures commercial centers follow patient selection guidelines, implant techniques and effective therapy method., • Facilitates local payer education and development process., • Works closely with marketing and sales operations teams to refine and enhance both organic and direct-to-patient outreach programs. WHAT YOU CAN BRING TO OUR GREAT TEAM Required: • Bachelor's degree with 2 years minimum sales experience in Medical Device or Pharmaceutical industry. In lieu of a degree, 5 years minimum sales experience in Medical Device or Pharmaceutical industry or 3 years previous experience at Inspire Medical Systems working directly with our therapy in a clinical setting., • Strong computer skills with MS office including PowerPoint and Excel., • Ability to manage simultaneous priorities, changing deadlines., • Experience with assisting in the implantation and follow up of implantable devices., • Experience in market development and building referral programs within the medical industry., • Product launch and account experience. #LI-Remote The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level. Salary$80,000—$80,000 USD BENEFITS AND OTHER COMPENSATION Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered): • Multiple health insurance plan options., • Employer contributions to Health Savings Account., • Dental, Vision, Life and Disability benefits., • 401k plan + employer match., • Identity Protection., • Flexible time off., • Tuition Reimbursement., • Employee Assistance program., • All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program. Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis. Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com Inspire Medical Systems participates in E-Verify.

Job DescriptionAbout the job This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Key Responsibilities: Primary Responsibilities • Assist in the preparation, formatting, and collection of regulatory submissions, • Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete., • Oversee inquiries into regulatory agency requests for additional information for document submission., • Support U.S. and EU market approval processes and ensure compliance with regulatory standards, • Support post-market submissions (progress reports, annual reports, etc.), • Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers., • Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.Compliance & Quality System Support, • Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745., • Support in audits (internal and external) in document preparation as needed., • Support document control and recordkeeping to ensure regulatory documentation integrity and traceability., • Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.Cross-Functional Collaboration, • Partner with Engineering and Clinical teams to gather information needed for submissions and documentation., • Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents., • Support training and awareness initiatives related to regulatory compliance., • Interpret new or existing regulations and ensure business practices align with compliance requirements., • Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance., • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership., • Establish and maintain regulatory information systems., • Contribute in continuous improvement initiatives and process optimization within Regulatory Affairs.Qualifications:, • Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred)., • Master’s degree in related field can count towards 1 year of relevant experience., • 3-5 years of experience in a regulated FDA environment (medical devices or combination products strongly preferred)., • Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus). Strong knowledge in regulatory strategy and approval approaches., • Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred., • Audit experience as a contributor is preferred., • Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project’s success., • Strong organizational, communication (verbal and written), and planning skills., • Ability to interact cross functionally across multiple departments with various levels of the organization., • Detail oriented, practical and proactive problem solver., • Proficiency with PC systems and office applications., • Solid understanding of scientific principles applied to regulatory affairs., • Understanding of regulatory and business needs with ability to engage cross functional team members.Salary range is $75,000- $85,000/annual USD An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits. We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email . Powered by JazzHR KfrVHAUAmF

Job Description Job Title: Technician III, Facility Maintenance (1st shift) Department: Engineering Job Purpose: Performs trouble shooting, repair, preventive, and corrective maintenance of facility equipment and building systems in assigned area(s) (may include: Utilities, facilities, and HVAC); Maintains key building systems (sprinklers, BMS, etc.), site utilities (boilers, chillers, USP water, HVAC, etc.), and building fabric. Major Accountabilities: Ensures all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards Continuously improves and broadens skills by participating in or initiating training Support Projects Involving New Equipment: advise Project Manager on the quality and suit-ability of proposed equipment, review equipment layouts, work with vendors, assist with validation efforts, write appropriate PM procedures, advise on which spare parts to procure, train teammates, etc. Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHAs Hazwoper standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. All employees that have received the above-mentioned training upon hire will receive annual re-fresher training that covers the Osha Hazwoper standard and the requirements of RCRA. Education: Associate degree in related field or technical equivalent required. Languages: Fluent in written and spoken English Experience: Minimum 6 years of work experience in manufacturing or maintenance environment is required. Experience in regulated environments such as pharmaceutical, medical device, food and beverage is preferred. Key Performance Indicators (Indicate how Performance for this Role will be Measured): Basic Microsoft Office Skills (Word, Excel and Visio) Fluent in English good communications skills both verbal and written, ability to read and understand SOPs and all forms of training materials. Must be available for overtime when needed, including evenings and weekends. Availability for emergency telephone support and call in rotation. Must be able to work in all areas of both Hicksville and Melville Facilities and follow gowning requirements where specified. Must be able to climb ladders and stairs, work in and through construction areas and lift 50 pounds.

Job Description Correct Job Title: Maintenance Mechanic Hours per day/week: 8/day 40/week Mon-Fri with a two Month flex to Tues-Sat schedule 2nd Shift 3 p.m. 11:45 p.m. Job Purpose Ensures the packaging of safe and effective product in an efficient manner. Ensures equipment is installed, set up, and maintained properly. Continuously improves production operations by performing any actions required to support departmental goals while adhering to safety and quality guidelines while reducing costs. Major Accountabilities Execute preventive maintenance (PM)/(work order) task lists and ensures proper documentation to maintain FDA compliant operation. Supports packaging operations as required, performs setups, trouble shoots, documents activities according to procedures, provides updates to GAMED system (as necessary), repairs packaging equipment, and provides other duties as required while maintaining operational efficiency and in a timeframe required to meet departmental expectations and efficiencies. (I.e, schedule adherence) Disassembles and cleans equipment as needed for efficient and proper line clearance. Operates machines by performing all necessary challenges and checks as per filling Instructions. Documents all maintenance, adjustments and repairs in the appropriate logbooks or documents. Assesses equipment condition and makes recommendations for maintenance activities as required to maintain operational efficiencies and performance. Assists in Engineering studies, Validation, FAT, Qualifications and provides input to equipment related SOPs. Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies (i.e. Lock Out/Tag Out), and current Good Manufacturing Practices (cGMPs). Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency and volume demands while not sacrificing quality or safety. Maintain effective communication between shifts. Coordinate with other departments as necessary to maintain efficiency of the lines. Adheres to all applicable procedures, cGMPs, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors. Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, employee must be trained under OSHAs HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA. To perform this job successfully, an individual must have satisfactory visual acuity. Visual acuity screenings may be used to screen applicants. Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected. Key Performance Indicators Effective preventive maintenance completion of assigned tasks including documentation per preventive maintenance guidelines. Maintain up time efficiencies by setting up and troubleshooting equipment and working effectively with the production/packaging/quality etc. teams. Maintain efficient change over times by executing with excellence and teamwork to expedite line clearance procedures. Support and implement safety initiatives, wearing all personal protective equipment (PPE), and displaying safe work performance according to company safety standards. Neat and organized work habits. Capable of multitasking and prioritization of activities to ensure schedule adherence. Able to work independently and professionally with others while performing any additional actions as necessary to meet departmental and organizational needs as necessary. Job Dimensions Number of associates: NA Impact on the organization: Medium Ideal Background Education : Associates degree or Technical School diploma and or combination of equivalent experience. Conceptual understanding of current Good Manufacturing Practices 21 CFR 211. Experience: Minimum of two years Packaging Equipment Experience. Preferred Documentation experience in food, drug, or cosmetics industry.

Job Description Founded in 1954, Vibrant Ingredients is a leading provider of natural, clean label ingredients and systems that power extraordinary food and beverage experiences. The company’s broad portfolio — including natural flavors, botanical extracts, functional nutrition, cold brew coffee, tea essences, and food protection solutions — enhances taste, texture, color, shelf life, and performance across a wide range of applications. Vibrant operates four state-of-the-art facilities across the United States and works with leading brands, manufacturers, and foodservice operators. With vertically integrated capabilities and a proven track record of innovation and execution, Vibrant helps customers accelerate to market without compromise. About the role: We are a trusted partner to our customers when it comes to innovation and an industry leader in clean label ingredients, we are a true partner. We collaborate with our customers in ways that respect people and the environment. A commitment to Purely Better™ drives our innovation team to discover new, on trend solutions. As a Senior Regulatory Manager, you will lead regulatory strategy and execution across multiple business units, guide regulatory compliance, and oversee the Regulatory Manager(s). This role partners closely with R&D, Quality, Commercial, and Operations teams to drive compliant product development, ensure market readiness, and support customer and regulatory engagement at a strategic level. How will you contribute: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. Essential job functions and duties include, but are not limited to: Regulatory Leadership & Strategy • Lead regulatory oversight for assigned business units and ensure compliance with U.S. and international food and flavor regulations (FDA, FEMA, EFSA, CFIA, USDA, TTB)., • Support the Director in developing and implementing regulatory strategies, policies, and long-term compliance plans., • Guide regulatory interpretation for new ingredients, formulations, claims, labeling, certifications, and market-entry needs., • Serve as a senior advisor to cross-functional teams on regulatory risks, opportunities, and best practices., • Participate in FEMA regulatory affairs meetings to stay informed on industry standards and emerging requirements. Team Management & Development • Supervise, mentor, and develop Regulatory Manager(s)., • Establish team priorities, KPIs, workload distribution, and resource planning., • Promote a culture of proactive compliance and continuous improvement. Product Compliance & Documentation • Oversee review and approval of product formulations, ingredient statements, claims, labels, and regulatory documentation., • Ensure accurate and timely development and maintenance of regulatory documents (TDS, SDS, allergen, nutrition, etc.)., • Lead regulatory assessments for new product development and ingredient qualification., • Ensure global market-entry requirements are met., • Provide expert-level regulatory guidance to internal teams and customers. Regulatory Intelligence & Risk Management • Monitor and interpret emerging global regulations, industry shifts, and scientific developments., • Conduct regulatory impact assessments and recommend product, process, or label changes., • Ensure preparedness for audits, inspections, and compliance reviews. Cross-Functional Collaboration • Partner with R&D, QA, Procurement/Supply Chain, Marketing, and Sales to guide compliant product launches., • Support customer relationships by offering high-level regulatory expertise during meetings and documentation reviews., • Collaborate with regulatory agencies to resolve issues and ensure compliance., • Partner with Quality on supplier approval, issue mitigation, crisis management, and corrective actions. Systems, Processes & Continuous Improvement • Drive harmonization and standardization of regulatory processes across business units., • Contribute to the development and maintenance of regulatory databases and digital tools. Minimum Requirements/Qualifications: • Bachelor’s or advanced degree in Food Science, Quality, Biology, Biotechnology, Chemistry, or related field., • 8+ years’ experience in food/beverage, ingredients, or related consumer goods industry with a preferred strong emphasis on flavor industry., • Strong working knowledge of global food and flavor regulations (FDA, FEMA GRAS, USDA, CFIA, EU, Organic, Kosher, Halal, TTB)., • Knowledge of Rainforest Alliance, Fair Trade, and Non-GMO Verification Project preferred., • Familiarity with AAFCO and IFRA a plus., • Experience managing regulatory audits and customer visits., • People-management experience required; experience supervising managers strongly preferred., • Experience supporting innovation pipelines and regulatory aspects of new product development., • Expert-level regulatory interpretation and problem-solving abilities., • Strong leadership, decision-making, and coaching skills., • Excellent communication skills for both technical and non-technical audiences., • Highly organized and capable of managing multiple complex projects simultaneously., • Ability to influence cross-functional teams and drive compliance-focused culture., • Generous time off for vacations, • Paid Holidays, • 401(k) with company match, • Tuition reimbursement, • Medical/Dental/Vision More about us: Vibrant Ingredients, headquartered in Lake Mary, FL, is one of the world's leading independent providers of natural ingredients. With a legacy spanning over 70 years, we deliver a diverse portfolio of clean label ingredients and innovative system solutions to the food and beverage industry. Our commitment to quality and performance is reflected in our American-made products, which enhance both taste and functionality. Backed by advanced manufacturing capabilities, we specialize in fermentation, patented cold brew extraction, custom flavor development, and a range of drying and blending technologies. Operating from four state-of-the-art facilities strategically located across the U.S., we ensure the accessibility of real, high-quality ingredients—helping our customers create better-for-you food and beverage for consumers. "Improving the food and beverages consumed by providing real ingredients from nature that work." This position is currently classified as on-site. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Holidays, Vacation, Tuition Reimbursement Program. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee’s employment term, at the sole discretion of management. EEO Statement Vibrant Ingredients is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Vibrant Ingredients will work with applicants to meet accommodation needs that are made known to Vibrant Ingredients in advance. Please no external recruiters

We are seeking a motivated and results-driven Pharmaceutical Sales Representative to join our team. Pharmaceutical Sales experience with demonstrated record of impact preferred. Maintains accountability for all pharmaceutical samples in accordance with FDA and PDMA guidelines.

Job Description Maintenance Technician – Food Manufacturing Location: [City, State] Job Type: Full-Time Industry: Food Manufacturing / Processing Position Overview We are seeking a skilled Maintenance Technician to support production and packaging operations in a food manufacturing facility. This role is responsible for preventive maintenance, troubleshooting, and repair of manufacturing and packaging equipment to ensure safe, efficient, and compliant production. The ideal candidate has hands-on mechanical and basic electrical experience, understands food-grade environments, and can respond quickly to minimize downtime. Key Responsibilities • Perform preventive and corrective maintenance on food processing and packaging equipment, • Troubleshoot mechanical, electrical, pneumatic, and hydraulic issues, • Maintain and repair conveyors, fillers, sealers, mixers, ovens, and packaging machinery, • Respond to equipment breakdowns and production support calls, • Perform machine setups, changeovers, and adjustments, • Conduct equipment inspections to ensure reliability and safety, • Read and interpret mechanical drawings and electrical schematics, • Document maintenance activities using CMMS or work order systems, • Follow GMP, HACCP, and food safety requirements, • 2–5+ years of maintenance experience in a food, beverage, or consumer goods manufacturing environment, • Strong mechanical troubleshooting skills, • Basic electrical knowledge (motors, sensors, wiring, controls), • Experience with conveyors and packaging machinery, • Ability to work independently and as part of a team, • Experience with high-speed packaging lines, • Pneumatic and hydraulic system knowledge, • PLC troubleshooting exposure (not programming-heavy), • Familiarity with FDA-regulated or GMP environments, • Welding or fabrication experience

Job Description Certified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries. We have embarked on an important journey to unify and strengthen our culture by living these core values: Start with the Customer, Drive to Deliver, Commit to Safety and Quality, and Believe in the Team — including believing in you. We are currently looking for a Courier to join our growing team! JOB SUMMARY Responsible for the safe and efficient delivery of food samples to our laboratory testing facility. The courier will provide exceptional customer services to clients of the company while operating a company vehicle to deliver and pick up test samples at customer sites. ESSENTIAL RESPONSIBILITIES • Responsible for assisting with maintenance of a company facility according to established schedules, • Must follow the Company Driving Policy, as well as all applicable state and federal driving laws., • Adhere to proper accident reporting procedures according to company policy, • Provide Excellent Customer Service Satisfaction at the point of pick-up, • Ensure safe and timely transport of the food products to our laboratory, • Responsible for operating the vehicle in a safe manner and to drive defensively to prevent injuries and property damage, • Work closely with the laboratory management and staff, • Drive vehicles with reasonable prudence to conserve fuel and sustain them at the highest operating efficiency, • Present the vehicle for repair, service, or adjustment whenever such is needed, and preventative maintenance when time is due, • Perform all activities in a neat, safe, hygienic, and efficient manner, • Assisting with managing priorities and schedule such that individual goals as well as team goals are achieved with encouraged participation in the Food Safety Net Services Team, • Complete assigned FDA Collections and Photo Report for samples collected from warehouses/freezers, • Responsible for the safety of oneself and others working within their area, • High School diploma or G.E.D, • 2 years of professional driving experience, • Training in general laboratory practices, • Will have a current, valid driver's license issued in the State of operation, • A driving record with no DUIs or major moving violations or accidents within the past 60 months, • Demonstrated professionalism, dependability and initiative in prior work experience, • Basic knowledge of concepts and practices of a testing laboratory preferred 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. • Regularly required to stand, sit, walk, use hands and arms, talk and hear, • Regularly lifts items up to 55 pounds, • Color vision and depth perception, • Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens, • Noise level varies from quiet to loud, • Temperature varies from hot to cold, • Progressive 401k Retirement Savings Plan, • Employer Paid Short- Term and Long-Term Disability, and Life Insurance, • Group Medical, • Tuition Reimbursement, • Flexible Spending Accounts, • Dental, • Paid Holidays and Time Off, • Many positions which qualify for the company bonus program Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status. Monday through Friday, 8:00 AM to 4:30 PM, overtime and weekends as required

Great contractor on Long Island is hiring for a Project Manager ASAP!.This Jobot Job is hosted by: Paul Madden.Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.Salary: $140,000 - $170,000 per year.Based on Long Island, we are a top construction company that

Are you a proactive hands-on warehouse person looking to use your customer service skills to build customer loyalty?.Are you an ambitious, hard working individual interested in career growth?.Do you have a valid driver's license and a clean driving record?.At Applied Industrial Technologies, the War

REMOTE MEP Design Engineer | Project Manager.Our client is a fast-growing MEP engineering firm providing high-quality mechanical, electrical, plumbing, fire protection, and fire alarm design services across New York City and beyond.Their work spans commercial, residential, hospitality, retail, and c

Ensure full adherence to ISO and FDA GMP standards.

REMOTE MEP Design Engineer | Project Manager.Our client is a fast-growing MEP engineering firm providing high-quality mechanical, electrical, plumbing, fire protection, and fire alarm design services across New York City and beyond.Their work spans commercial, residential, hospitality, retail, and c

Ensure full adherence to ISO and FDA GMP standards.

One of our clients, a major electronics manufacturer is looking for a talented.Permanent position with excellent compensation package and benefits.Location: Metro NY (Huntington Station area onsite).Must be authorized to work for ANY employer in US.Please read the description below and to be conside

Work with our vendors to be fully compliant with FDA guidelines.

Sciens Building Solutions seeks an experienced Fire Systems Project Manager (PM) responsible for the execution of fire and life safety system projects in accordance with project budgets, code compliance, and managing the field operations team’s work quality and work output.This position will work

Join our Natural Organics Inc / Natures Plus Family!.For more than 50 years, Natural Organics Inc.Melville, NY has been the gold standard in natural vitamins and supplements.Marketing our products under the Natures Plus brand, we are committed to producing the finest, most effective formulations ava

Warehouse Picker Order Selector- Melville, NY.Accurately pick products by matching numbers and products using voice audio headset.Hand stack cases of product weighing up to 50 pounds repetitively from floor to over-head.Place the beverage products in a defined stacking pattern onto the pallet.Hand s

Influence Precision Manufacturing.An established, globally backed precision manufacturing organization in the Rochester area is seeking a Senior Quality Engineer to lead and strengthen its Quality Management System and drive operational excellence.This is a high-visibility role within a technically

For more than six decades, the skilled thinkers, makers, and doers at Frontgrade have embraced our mission to solve complex technology challenges across the U.We're the leading provider of high reliability and radiation assured solutions for defense, space, intelligence, commercial, and civil applic

Looking for an experienced Business Analyst/Project Manager who will be responsible for understanding and assessing the changing needs of the business.Frequently analyze the impacts of change, document and support communication between relevant groups and stakeholders, and capture requirements neede

Influence Precision Manufacturing.An established, globally backed precision manufacturing organization in the Rochester area is seeking a Senior Quality Engineer to lead and strengthen its Quality Management System and drive operational excellence.This is a high-visibility role within a technically

REMOTE MEP Design Engineer | Project Manager.Our client is a fast-growing MEP engineering firm providing high-quality mechanical, electrical, plumbing, fire protection, and fire alarm design services across New York City and beyond.Their work spans commercial, residential, hospitality, retail, and c

Join Our Team: Full-Time Warehouse Associates Available!.Are you ready to be part of a dynamic and rapidly expanding company in the heart of Long Island? Nassau Candy Distributors, Inc.We are currently seeking dedicated individuals to join our team for the following positions:.Full-time positions wi

Retail Warehouse & Production Associate.Our starting pay ranges from $16.Who we are: As one of the largest for-profit thrift operators in the United States, Canada and Australia for value priced pre-owned clothing, accessories and household goods, our mission is to champion reuse and inspire a futur

At PennEngineering, we innovate and collaborate to make the world a better place.You can contribute to work that matters with a company where diversity, equity and belonging are shared values.We're committed to fostering an environment for every employee that's welcoming, respectful and inclusive, w

As a warehouse associate at Floor & Decor, you are the backbone of our retail location.Your key responsibilities will be compiling orders and replenishing and moving merchandise, whether it be on the sales floor or to a customer's vehicle.Your day will be spent checking inventory and orders, interac

Oversees, maintains, and repairs building support systems in a complex, warehouse environment.Also, performs maintenance related functions in support of warehouse operations.This role plays a critical part in sustaining operational efficiency and safety standards through proactive upkeep and repair

Warehouse Associates perform a variety of warehouse responsibilities including but not limited to loading, unloading, selecting, freight hauling, auditing, repacking, sorting, palletizing, clean up, housekeeping and other duties as assigned by site leadership.High-energy individual with a strong wor

At Harold Levinson Associates, we deliver to the convenience store industry and are looking for qualified applicants to join our team.We are headquartered out of Farmingdale, NY and continue to grow.Presently, we have immediate openings for Warehouse Associates.Prior warehouse experience preferred b

Now hiring a Part-Time Packer, where you will assist with packaging, labeling, and preparing items for delivery, coordinate with other departments when needed, and respond to questions by phone, email, or in-person.Additional duties include work with supervisors to meet daily goals, handle orders, s

Warehouse Picker Order Selector- Melville, NY.Accurately pick products by matching numbers and products using voice audio headset.Hand stack cases of product weighing up to 50 pounds repetitively from floor to over-head.Place the beverage products in a defined stacking pattern onto the pallet.Hand s

We’re looking for a Amazon Picker/Packer to perform daily responsibilities with dedication.Work with your team to maintain efficiency and service quality.Ensure compliance with company and safety standards.Perks include competitive pay, flexible schedules, hands-on training, a collaborative workpl

Are you energized by a warehouse operations role that allows you to enhance your skills in a state-of-the-art manufacturing environment? If so, this Inventory control mover role could be an exciting opportunity to explore.As a Warehouse Mover, you will be responsible for the receipt, administration,

Experience with knowledge management processes, learning and development and APQC preferred.Master’s degree preferred in either a technical or business discipline.PMP Certification or formal project management training preferred.Technical Project Manager (Contract).Technology team, reporting to th

Packer Job Duties: Pulls and stacks product based on daily orders.Meets specifics of customer orders in a timely manner.Keeps products separated, organized, and in good rotation.Moni

Looking for an experienced Business Analyst/Project Manager who will be responsible for understanding and assessing the changing needs of the business.Frequently analyze the impacts of change, document and support communication between relevant groups and stakeholders, and capture requirements neede