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Job Title: Supervisor Location: SBC Corporation Department Name: Lab NBI Req #: 0000234024 Status: Salaried Shift: Day Pay Range: $93,150.00 - $113,850.00 per year Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. Step into a fast-paced, deeply rewarding role where the work you do truly matters. As the Laboratory Supervisor of the Blood Bank at Newark Beth Israel, you will be a key member of the patient care team and collaborate with physicians and other clinical professionals to contribute to safe and effective care. The Lab Supervisor may be the perfect role for you if you have strong leadership skills, knowledge of specialized principles and techniques in Blood Banking, and want to make a difference in the lives of our patients. If you are passionate about healthcare, eager to advance your skills, and motivated to make a tangible difference during every shift, this position provides the experience, challenge, and purpose you are seeking. As the Laboratory Supervisor of the Blood Bank at Newark Beth Israel, below are your key responsibilities: • Day-to-day operational oversight of the Blood Bank / Transfusion Services, • Ensure safe, accurate, and timely provision of blood and blood components, • This role provides technical leadership, staff supervision, regulatory compliance oversight, and quality assurance in accordance with AABB, CAP, CLIA, FDA, and hospital policies, • Perform or supervise complex immunohematology testing (ABO/Rh, antibody identification, crossmatching) and component modification (irradiation), • Review records of blood testing, processing, and transfusion reactions; manage Occurrence Report Forms for process improvement, • Supervises duties related to record documentation, consults with Medical Director and Administrative Director on regulatory compliance updates, • Participates in the administrative and budgetary operations of the section The Laboratory Supervisor role might be for you if you: • Have previous experience in Laboratory leadership at a high-volume healthcare facility, • Have previous experience working in a Blood Bank, • Excellent customer service, • Outstanding communication skills including verbal and written To be considered for this opportunity, you must have a Bachelor of Science or Medical Technology degree and Minimum of 3 years experience as a medical technologist. ASCP or NCA certification preferred. Benefits and Perks: At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees’ physical, emotional, social, and financial health. • Paid Time Off (PTO), • Medical and Prescription Drug Insurance, • Dental and Vision Insurance, • Retirement Plans, • Short & Long Term Disability, • Life & Accidental Death Insurance, • Tuition Reimbursement, • Health Care/Dependent Care Flexible Spending Accounts, • Wellness Programs, • Voluntary Benefits (e.g., Pet Insurance), • Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more! Choosing RWJBarnabas Health! RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health. RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey—whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education. Equal Opportunity Employer

Territory: Queens, NY - Psychiatry Target area for territory is Queens - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: all of Queens, NY as well the Great Neck portion of Nassau County, NY. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Self-starter, with a strong work ethic and outstanding communication skills., • Must be computer literate with proficiency in Microsoft Office software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder., • Documented successful sales performance., • Ownership and accountability for the development and execution of fully integrated account plans., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Experience in product launches., • Previous experience working with alliance partners (i.e., co-promotions)., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is specifically for those potential hires who will work or reside in the state of New York, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $125,000 - $147,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Territory: Manhattan South, NY - Neurology Target area for territory is Manhattan - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: 60th street and South. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It’s a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method. Customer Development - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals. Payer Access - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Ownership and accountability for the development and execution of a fully integrated account plans., • Self-starter, with a strong work ethic and outstanding communication skills., • Proven track record of consistent sales performance., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Must be computer literate with proficiency in Microsoft Office Software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement., • Neurology experience specific to migraine., • Experience in both the medical or specialty pharmacy benefit market., • Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care., • Product launch or expansion experience, particularly in a new therapeutic class., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to a regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $155,000 - $172,000 and eligibility for a sales incentive target of $41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Territory: Brooklyn South, NY - Neuroscience - Psychiatry Target city for territory is Brooklyn - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Prospect Heights, Coney Island, Bay Ridge and Flatbush. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager, you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional Accounts such as community mental health centers and hospitals, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Neuroscience Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university, • 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience, • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually, • Self-starter, with a strong work ethic and outstanding communication skills, • Demonstrated skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network, • Must be computer literate with proficiency in Microsoft Office software, • Must live within 40 miles of territory boundaries, • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder, • Documented successful sales performance, • Ownership and accountability for the development and execution of fully integrated account plans, • Strong analytical background, and experience using sales data reporting tools to identify trends_, • Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals, • Sales experience with buy & bill/injectable products, • Experience in product launches, • Previous experience working with alliance partners (i.e., co-promotions), • Strong leadership through participation in committees, job rotations, panels and related activities TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is specifically for those potential hires who will work or reside in NYC, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $135,000 - $165,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

Job Description | Quality Manager, Partners Title | Quality Manager, Partners Location | Hybrid (Totowa, NJ) Department | Quality/Regulatory/EH&S Reports To | Director, Quality Management, Partners & Training Compensation: $90-100k Overview SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Director, Quality Assurance, Partners & Training, and provides Quality leadership to the Radiopharmaceutical Contract Manufacturing (RCM) division throughout the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This person will play an active and integral part of the Quality team supporting compliance, improvement, and implementation with all RCM products at all SOFIE facilities. Essential Duties and Responsibilities Provide quality assurance support to the Radiopharmaceutical Contract Manufacturing (RCM) group within the SOFIE Network. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products. Be a quality liaison, develop solid relationships, and establish open communication with SOFIE partners and sponsors. Assist in the roll-out of new products at SOFIE network sites. Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, and continuing to establish an effective and efficient quality management system at one SOFIE facility, at minimum, and companywide. Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS). Assist Director, RCM, Directors, Quality Management, Directors, QA and Regional Managers, QA with quality initiatives, decisions, and training, etc. Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA when necessary. Closely track and follow-up on these activities for timely closure. Ensure that scientifically sound investigations are conducted, and root causes are identified. Initiate and implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending. Author and review cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents. Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions. Assist with the ongoing training program and present training presentations on applicable job-related procedures and topics. Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues. Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements. Liaise with corporate QA for audits, customer audits, partner audits, and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summarize and report auditing progresses daily during each audit. Prepare complete responses to the audit outcomes on time. Ensure corrective actions being implemented according to the committed timelines. Review partner customer/patient complaints to determine the possible root causes. Work with the partners and customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively. Maintain knowledge of current regulations and quality policies. Attend quality related meetings and conference calls. Interface with corporate QA on quality related issues. Provide quality status updates as required by corporate QA. Be a Subject Matter Expert resource for the entire network for the key area: Radiopharmaceutical Contract Manufacturing (RCM). \ Author or review certain sections of regulatory submissions, including responses to regulatory inquiries as needed. Perform other tasks as required. Qualifications Bachelor of Science Degree (B.Sc.) in an appropriate scientific subject, e.g., Chemistry, Microbiology, Quality and Regulatory Affairs, Regulatory Science, etc. preferred but will entertain applicants with relevant education and work experience. 2+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred. 1+ years’ supervisory experience within a Quality Assurance or Quality Control function preferred. Experience with FDA regulatory submissions (establishment registration, safety reports, annual reports, amendments, etc.) preferred. Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred. Working knowledge of US and ICH cGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required. Experience leading internal audits preferred. Knowledge of current FDA enforcement issues preferred. Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required. Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required. Ability to prepare and present written and verbal reports to upper management required. Ability to project manage and have excellent organization and prioritization skills. Travel: up to 50% domestically.

Job Description: QC Chemist II, Radiopharmaceutical Contract Manufacturing, NJ5 Title QC Chemist II Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.004 Overview: The QC Chemist II will perform analysis of diagnostic and therapeutic radiopharmaceuticals for SOFIE within the Radiopharmaceutical Contract Manufacturing Division. Following SOFIE's QA program and cGMP guidelines, they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and EudraLex Volume 4). Essential Duties and Responsibilities • Conduct required Quality Control analytical tests for regular production of radiopharmaceuticals for preclinical, clinical, or commercial use according to cGMP standards. • Prepare standards, samples, and mobile phase solutions for analytical methods. • Ability to perform precise production visual inspection or laboratory appearance testing of finished product requiring 20/20 vision and accurate color differentiation (with or without reasonable accommodation) to assess product quality by evaluating color, clarity and absence of visible particulates for the drug product solution and evaluating attributes of the container closure system (e.g., cracks or chips in glass vials, creases in crimps, presence of stoppers, color of flip tops, etc.) in compliance with FDA, EudraLex and Rest of World guidance. • Initiate deviation and OOS reports, lead root cause investigations • Assist in the development, implementation, and validation of Quality Control analytical methods • Follow protocols for the analysis of clinical-grade radiopharmaceuticals, validate these methodologies against quality requirements, and implement them for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. • Validate existing analytical methods on existing or new equipment. Follow method transfer protocols for clinical and commercial-grade radiopharmaceuticals. • Write clear Standard Operating Protocols (SOPs) for QC protocols. • Review existing SOPs and suggest logical modifications based on either scientific rationales and/or regulatory requirements. • Install, qualify, and maintain laboratory equipment on site. • Collaborate with production radiochemists as required to ensure successful protocol development and radiopharmaceutical production. • Perform release testing, according to SOPs, on other materials (e.g., raw materials for radiopharmaceutical production). • Conduct environmental monitoring of environment and facilities. • Maintain all qualification and validation requirements for entering ISO classified areas. • Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. • Maintain accurate radiopharmaceutical test and validation results. • Liaise with our contract partners as needed (e.g., biotech and pharma). • Other duties as assigned. Qualifications • Bachelor's degree in Chemistry or natural science required with 2+ years of experience in analytical chemistry and instrumentation (qualification, troubleshooting and maintenance) required; a Master's degree preferred. • Experience in a GMP manufacturing environment is highly preferred. • Expertise in laboratory procedures and analytical chemistry techniques required (thin layer chromatography, GC, HPLC, preparative HPLC, Radiometric Detectors, endotoxin, etc.). • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required. • Efficient in the use of MS Office Suite required.Ability to be detail-oriented, accountable, patient, organized, and work in a team environment with minimum supervision required. • Strong technical writing skills required. • Excellent organizational skills required. • 20/20 natural or corrected vision and normal color vision, only for performance of visual inspection or appearance testing. • Ability to work various shifts and weekends required.

Responsible for receipt and documentation of Safety information for Marketed and Investigational Products. Interacts with health professionals and consumers to obtain and follow-up reports of possible adverse events with company products. Provides product information to health care professionals, consumers, and sales representatives. Codes and enters information into the global safety database. Verifies the accuracy, completeness and validity of information for each adverse event report for which he/she is responsible. Assures consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities. Accurate and timely data entry of both domestic and foreign adverse event and serious adverse event information into the PSSS (Product Safety Surveillance System) consistent with the ARISg coding manual, SOPs/WIDs, process flows and established time frames within the ARISg workflow. Full understanding of the products’ company Core Data sheet, PI, and/or IB for accurate labeling and listedness. Perform appropriate and timely follow-up per department guidelines, including accurate and thorough communication documentation within the case. Maintain proficiency in the utilization of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of successful distribution and acknowledgement. Maintain sufficient knowledge of all company products to ensure professional and knowledgeable discussions with consumers and healthcare providers and dissemination of accurate product information in response to queries. Provide high level customer service to consumers, health care professionals and internal customers. Complete all required training within the timelines provided so as to ensure knowledge of all relevant corporate and departmental SOP’s, SWP’s and WID’s. Ensure timeliness in regulatory compliance Gather sufficient information to assess the medical significance of an adverse event report, while at the same time assuring the information provided adequately addresses the concerns of the health care provider and/or consumer. Required Qualification & Skills: Bachelor’s degree in Medical field with RN or RPh licensure, or PharmD/MD degree required. Minimum 2 to 4 years in industry application of clinical medicine/pharmacy with a minimum of 1 year in pharmaceutical drug safety Experience in verbally interviewing and/or providing medical information to health care professionals and consumers Application of clinical medicine to patient care Medical terminology and standards of patient care Computer proficiency

Position R&D Regulatory Compliance (Entry level) Department R&D Classification Non-Exempt Reports to Director of R&D and Technical Sales Job type Full-time (on-site) Job Summary This role combines regulatory compliance and hands-on product development within a fast-paced food manufacturing environment. You will support food labeling compliance while also assisting in the creation of innovative seasoning blends alongside the R&D team. Responsibilities include reviewing and preparing product labels and documentation to ensure compliance with FDA, USDA, and international regulations, as well as maintaining accurate records and supporting audits. This is a hands-on, non-routine role ideal for a detail-oriented and motivated individual eager to gain real-world experience in both regulatory compliance and food product development. You’ll collaborate with cross-functional teams and play a key role in bringing new food products from concept to market. Key Responsibilities: • • Assist in creating and reviewing product labels and specifications, • • Ensure compliance with food regulations and customer requirements, • • Support documentation for domestic and international products, • • Research regulations and help resolve labeling questions, • • Work with cross-functional teams (marketing, operations, etc.), • • Maintain accurate records and support audits or compliance checks, • • Help improve internal processes and compliance procedures What We’re Looking For • • Basic knowledge of food labeling regulations (FDA, USDA, and international), • • Strong research and problem-solving skills, • • Detail-oriented with good organization and time management, • • Able to handle multiple tasks and adapt in a fast-paced environment, • • Good communication and teamwork skills, • • Proficient in Microsoft Office (Excel, Word, PowerPoint), • • Bachelor’s degree in Nutrition, Food Science, or related field, • • Some experience or internship in food labeling or regulatory work preferred Why This Role Stands Out This is a rare opportunity to break into the food industry in a meaningful way. You won’t just observe—you’ll actively contribute, learn rapidly, and gain hands-on experience that can accelerate your career. We are looking for individuals who are ready to work hard, stay curious, and grow. Work Location: 1835 Burnet Ave, Union NJ 07083 Compensation/ Benefits • • Competitive base and bonus, • • 401k, • • Medical, Dental, Vision, • • Life Insurance and AD&D, • • 12 Holidays, • • 7 Flexible days, • • 10 Vacation Days and more This is an excellent opportunity to kick-start your career in the field of culin ry research and development. If you are enthusiastic, reliable, and excited about contributing to the creation of unique and flavorful seasoning blends, we encourage you to apply for the Seasoning Blending Lab Technician position." Our Motto: One Team – One Goal The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Furthermore, they do not imply or establish a contract for employment and are subject to change at the discretion of the employer. EEO Statement: Kalustyan Corporation and its subsidiaries is an equal opportunity employer which does not discriminate on the basis of race, color, sex, sexual or affectional preference, gender, sexual orientation, gender identity or expression, religion, creed, ancestry or national origin, age, disability, marital or domestic status, veteran status, genetic information, atypical hereditary cellular or blood trait, or any other protected class. This policy applies to all employment actions including but not limited to, recruitment, selection, training, promotion, transfer, layoff, termination, and job-related social or recreational programs. If you need a reasonable accommodation for any part of the employment process, please contact us by email at hr@kalustyan.com and let us know the nature of your request and your contact inormation Requests for accommodations will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Company Description Lagniappe Foods is a dynamic and forward-thinking food production company dedicated to providing high-quality food products to meet the diverse needs of our customers. We pride ourselves on delivering excellence while adhering to the highest standards of safety and sustainability. As a growing organization, we value innovation, teamwork, and a commitment to continuous improvement in every aspect of our operations. Joining Lagniappe Foods means contributing to a brand that is passionate about quality and customer satisfaction. Role Description The Assistant Quality Assurance Manager will support the quality assurance team in ensuring food products meet regulatory and company standards. Key responsibilities include overseeing quality control processes, reviewing compliance with safety protocols, conducting inspections, preparing reports, and assisting in the development of quality improvement initiatives. This is a full-time, on-site role located in Orange, NJ, requiring hands-on involvement in daily operations. Qualifications • Quality Assurance and Control skills, including knowledge of quality management systems and ability to implement quality standards, • Experience with regulatory compliance and food safety standards, such as HACCP and FDA regulations, • Strong analytical skills for identifying issues, problem-solving, and implementing corrective actions, • Excellent communication and leadership skills for team collaboration and providing clear guidance, • Proficiency in creating reports and analyzing data to monitor processes and improve performance, • Attention to detail and the ability to work under pressure in a fast-paced environment, • Bachelor’s degree in Food Science, Biology, Chemistry, or a related field, • Prior experience in food production or quality assurance is highly desirable

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. Perform other work-related duties as assigned. Required: Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. Bias toward action, with a track record of driving execution aligned to organizational strategy. Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. Willingness and ability to travel approximately 10-15%. Preferred: Advanced degree (MS, PhD, or PharmD) strongly preferred. Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: Thrive Together - Collaborate intentionally, grow as a team Make It Happen - Focus on priorities, embrace continuous improvement Commit to Service - Cultivate a service mindset Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

The Director, Medical Affairs (Nutrition) is responsible for leading and managing medical affairs for approved nutrition products and those in development. Areas of support include Product pre-launch and launch activities, Product Development, Product Lifecycle management, Business Development, and Post-Marketing medical affairs strategies. Collaborates cross-functionally and globally to ensure corporate goals and objectives are met at the highest levels. Directs the Region's medical needs for support of drugs and devices on the market, in development, and under evaluation. Responsible for cultivating and maintaining external relationships esp. with Health Care Providers (HCPs) and/or Health Care Decision Makers (HCDMs) to enable comprehensive scientific exchange around disease states and associated Company products. Must maintain scientific expertise in the application of treatment guidelines and clinical data as it pertains to disease states and associated Company products. Must be able to communicate complex medical and scientific concepts to a broad range of audiences. The Director, Medical Affairs, will also support execution of Medical Affairs strategy and activities where and as appropriate. The Director, Medical Affairs will lead the field clinical education team and ensure that the respective territory engagement plans are effectively executed per defined targets, following Fresenius Kabi compliance rules and code of conduct and that relevant medical and scientific insight is routinely shared to optimize the Medical Affairs strategy for the nutrition portfolio. *Priority will be given to candidates in the Chicagoland area who are able to regularly work at our Lake Zurich, IL site. *This position does not offer visa sponsorship either now or in the future. • Salary Range: $185,000-220,000., • Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary., • Position is eligible to participate in our medium-term incentive plan., • Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities., • Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage., • Lead the strategic planning, launch, and lifecycle support of nutrition products including high-risk medications., • Lead the development and execution of medical affairs strategy to support successful product launch ensuring alignment with commercial, clinical development, regulatory teams and internal stakeholders., • Maintain the highest levels of professional integrity & performance standards by consistently providing high quality medical deliverables on time. Maintains a high standard for medical and scientific accuracy, representative of a comprehensive understanding of the medical concept at hand. Maintains a high level of professional expertise by staying abreast of current medical landscape with regard to key clinical conditions our products support., • Identify, engage, and build strong relationships with Key Opinion Leaders (KOLs), influencers in HCP community, scientific experts, and medical societies to support scientific exchange and advocacy., • Lead the nutrition team ensuring achievement of compliant and effective healthcare professional interaction for scientific exchange related to disease states and/or associated Company products per predefined engagement plans and targets., • Establish and maintain relationships with HCPs and HCDMs to provide scientific exchange related to disease states and/or associated Company products., • Represent the company at major medical and scientific conferences; manage planning and coordination of congress activities, including symposia, medical affairs booth presence, and thought leader engagements., • Oversee publication planning and execution, including abstracts, posters, manuscripts, and scientific communications, ensuring timely and compliant dissemination of clinical data., • Drive medical education initiatives for internal and external stakeholders, including training programs, advisory boards, and peer-to-peer education aligned with the product's scientific platform., • Provide scientific leadership and oversight for Investigator-Initiated Trials (IITs), including review, approval, and ongoing collaboration with investigators., • Collaborate cross-functionally to design and implement company-sponsored clinical studies to support product differentiation, real-world evidence generation, cost-effectiveness analysis, HEOR studies and post-marketing commitments., • Lead and manage a team of medical affairs professionals; provide coaching, development, and performance management to ensure high team effectiveness., • Collaborate with Global Medical Affairs in the support of USA-based clinical trials, both internal and external., • Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications., • Serve as a medical expert for on market parenteral nutrition products, products in development, and potential acquisition targets providing medical affairs strategies and due diligence for on market products and business development opportunities., • Responsible for writing and/or review of relevant Standard Operating Procedures (SOPs) pertaining to the role as needed. Job Requirements: • Medical/clinical professional degree required, such as Licensed Registered Dietitian., • Clinical Nutrition knowledge is required., • 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required., • 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens., • 5+ years of clinical experience preferred., • 5+ years of direct people management experience with demonstrated ability to develop and lead high-performing teams., • Ability to understand and interpret the regulatory requirements under which drugs and devices are developed, reviewed, and supported after approval., • Experience with the clinical drug development process and product launch experience is highly preferred., • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents., • Position will require travel (20-50%), including overnight stays. A valid US driver's license and clean driving record are required., • Ability to understand and interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements., • Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required. We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. This role will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. Make judgments about the operational impact of proposed actions, and identify, and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies. Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. Perform other work-related duties as assigned. Required: Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience. 10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry. 7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports). Review and approval of product labeling and promotional and advertisement brochures and multimedia content. Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s). Previous people management experience. Excellent interpersonal, teamwork, and verbal/written communication skills. Good organizational skills and an ability to manage multiple tasks/projects/priorities. The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed. Ability to mentor and coach junior level staff as well as cross-train with peers. This position is not currently eligible for visa sponsorship. Preferred Direct experience with FDA CBER. Experience hosting or supporting Pre-Approval Inspections for either FDA, EU Notified Bodies or both. RAC (Regulatory Affairs Certification). Medical Device and/ or Pharmaceutical Industry experience is highly desirable. CE Mark under IVDD and current IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations is a plus. Use of Process Excellence (PEx) tools for process improvement initiatives. Internal Partners: Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality/Manufacturing Quality, Regulatory Affairs Managers/Directors, QO International and Regional Regulatory Affairs groups External Partners: Regulators in worldwide markets, for example TUV/BSI, FDA, Health Canada, etc. Third Party Contract Manufacturers and Suppliers. Use of a computer is required. Traditional office workspace or remote home office location. On occasion, may require up to 20% of domestic/international travel. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $155,677.15 - $202,380.30 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-HF1

Job DescriptionSUMAMRYThe Packer is responsible for accuracy of bag weights, sealing and labeling of bags, coding of bags, checking to be sure the correct bags are being packed, and ensuring volume of output. They are also responsible for keeping the work area neat and clean. Packers may be assigned other duties as needed by the Manager/Supervisor.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Operate the pack line in an efficient manner to meet operating targets for efficiency, downtime, and minimal rework, • Repair pallets of finished product as they occur (broken bags, missing labels etc.), • Operate Forklift, • Pull pallets of flour from packing line and place them accurately in designated storage areas with proper scanning using Scanwork, • Operate tote packer; fill totes with farina, whole wheat, flour, etc., • Understand and use Scanworx inventory system in regards to warehouse packing supplies and finished product movements, • Understand policies and procedures set forth by BSM, USDA & other applicable food production entitiesQUALIFICATIONS 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., • Must have operational knowledge of packing equipment, including a Packer, Check-Weigher, Stacker/Bundler, Palletizer, and Stretch Hooder, • Must be capable of trouble-shooting common issues and communicating problems to maintenance/management, • Must be Forklift Certified, • Must be able to communicate in English, both verbal and written, • Must be able to perform basic math functions, with or without the aid of a calculator, • Must be capable of learning computer entry, • Must be an independent worker with self-initiative to carry out job functions, • Must be willing to rotate shifts and cover absences if requiredPHYSICAL 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., • Must be able to work in an environment, which has extremes in temperature, • Must be able to climb ladders, • Must have physical dexterity to perform basic repair functions, • Must be able to stand for extended periods of time, • Must be able to bend, stoop, kneel, crouch, twist and crawl frequently, • Must be able to frequently lift and/or move 50 pound bags, • Vision requirements are close vision, distance vision, color vision and depth perceptionWORK 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.While performing the duties of this job, the employee is regularly exposed to moving mechanical parts, and fumes or airborne particles. The employee is exposed to vibrations. The employee is occasionally exposed to high precarious places. The employee will be exposed to extremes in temperature, both hot and cold. The work environment is noisy, at times in excess of 100 decibels.FOOD SAFETY / SECURITY AND QUALITY REQUIREMENTSThe Company is committed to producing and delivering defect free products that are in compliance with all applicable legal and regulatory requirements and are of the highest levels of food safety, quality and productivity. To ensure this, all employees are required to be trained on and adhere to the FDA Current Good Manufacturing Policies as set forth by the Company as they pertain to personnel practices, equipment and facilities. It is also vital that all employees be aware of their work environment and prevent any accidental or intentional adulteration of the products produced at the facility.FULL-TIME/PART-TIME: Full timeSALARY: $25.49AVAILABILITY: Open AvailabilityPOSITION: Packing OperatorNUMBER OF OPENINGS: 2LOCATION” Strike Force Staffing- Clifton, NJ

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua

Have strong experience with one or more of: AML/BSA, OFAC sanctions screening, FCPA/anti-corruption, healthcare regulatory (HIPAA, Stark Law, Anti-Kickback Statute, Medicare/Medicaid), FDA submissions, privacy (GDPR/CCPA/PIA/DPIA), environmental permitting, export control, or administrative hearings

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for internal, domestic and international compliance activities. Prepare comprehensive regulatory strategies for new devices and post market changes. Clearly communicates strategies to RA management., project teams and business unit leadership. Preparing regulatory filings for new products, as well as post market changes. As necessary, reviews complex regulatory issues with RA management. Job Responsibilities and Essential Duties • Professionally negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management., • Prepares Regulatory strategy/plans and requirements., • Prepares documentation and coordinates activities related to EuMDR, PMA amendments, PMA supplements, PMA annual reports, Q-subs, 510(k)s and IEDs., • Prepares worldwide regulatory submissions/registrations including collecting information and documentation for submissions to regulatory agencies., • Update/maintain basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency., • Participates in the review and disposition of labeling, promotional material and product modifications., • Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations, the MDD, EuMDR, CMDR, and other international regulations., • Complies and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirement and tracks timeline through review process to ensure timely submission., • Participates in cross-functional departmental team projects and products development activities/meetings., • Support with Field Correction and Recall activities, • Responsible for FDA/ISO/MDD/MDR/CMDR compliance documentation, • Participates in and support internal and third-party audits, • Assists in special projects as needed, • Contributes to team effort by accomplishing related duties as requested Minimum Requirements • Bachelor's Degree and a minimum four years of directly related experience in Regulatory Affairs in a medical device environment, or a minimum ten years of directly related experience in Regulatory Affairs in a medical device environment., • Experience wit the preparation, submissions and approval for medical devices is required including 410(k) or PMA., • Understands the requirements of FDA 21CFR Part 820, EU MDD, EU MDR, MDSAP, CMDR and ISO 13485., • Proficient computer skills, including MS office applications (Word/Excel) are required. Required Knowledge, Skills and Abilities • Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment., • Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills., • Demonstrated proficiency in regulatory planning and strategy submissions along with strong negotiation skills., • Ability to represent Regulatory Affairs to other departments., • Working knowledge of principle compliance focused ISO Standards (13485, 14971, 62366) and the use of ISO Standards as special controls. Supervision/Management Of Others: None Internal and External Contacts/Relationships • Maintains effective relationships with internal customers., • Build relationships and participates as a member of a cross-functional product development team., • Professionally negotiate/communicate directly with regulatory entities (e.g., governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. Environmental/Safety/Physical Work Conditions • Ensures environmental consciousness and safe practices are exhibited in decisions, • Use of computer and telephone equipment and other related office accessories/devices to complete assignments, • May work extended hours during peak business cycles About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview • This position provides technical leadership in the development, optimization and sustaining of manufacturing processes for medical devices in accordance with Getinge's Quality system and regulatory requirements (ISO 13485 and FDA 21 CRF Part 820)., • This individual is a key resource during Design for Manufacturability (DFM), collaborating closely with cross-functional teams to ensure current and new products are scalable, robust, cost-effective, and production-ready., • Leadership cross-functional initiatives, drive strategic improvements, oversee process validations, implement continuous improvement strategies, and support commercial-scale operations. Job Responsibilities and Essential Duties Design for Manufacturability (DFM), Design For Six Sigma (DFSS) & Product Development • Establish and standardize DFM and DFSS best practices, templates, and guidelines across engineering teams., • Lead early design phases to influence product architecture, material selection to ensure scalability, robust manufacturability, and cost-optimized solutions, • Drive Design for Six Sigma methodologies (DMADV/IDOV) during product development to ensure critical-to-quality (CTQ) requirements are met., • Integrate Design for Cost (DFC) principles into product and process development, ensuring costeffective material choices, processes, and tooling strategies., • Provide technical leadership in DFM reviews, tolerance analyses, design risk assessments, and capability studies., • Translate product requirements into manufacturing specifications, tooling designs, and process control strategies., • Support prototype builds and pilot manufacturing, documenting design/assembly issues and implementing corrective actions. Process Development & Validation • Develop and optimize manufacturing processes including molding, machining, laser processing, automated assembly, packaging, and/or sterilization workflows., • Lead large scale process validations (IQ/OQ/PQ), process characterization efforts, and statistical justification aligned with regulatory expectations., • Establish longterm process capability targets, implement control strategies, and ensure audit readiness., • Apply DFSS tools such as DOE, and tolerance stackups to guide process optimization. Manufacturing Support & Continuous Improvement • Serve as the technical escalation point for complex manufacturing challenges, driving root-cause investigations and high-impact CAPAs to closure., • Lead yield improvement initiatives, cost-reduction programs, and process harmonization across multiple product families., • Partner with Operations and Quality to enhance throughput, reduce scrap, optimize workflow, and expand manufacturing capacity., • Lead Lean/Six Sigma initiatives targeting waste reduction, workflow optimization, and standardization. Cross-Functional Collaboration • Act as the primary technical interface in a cross-functional team as a Core Team member, • Lead technical discussions with suppliers on component manufacturability, material selection, tooling design, and qualification of new technologies., • Apply Design for Cost and Lean principles to reduce waste, optimize workflow, and lower overall cost of goods., • Partner with Operations and Quality to enhance throughput, reduce scrap, and expand manufacturing capacity. Minimum Requirements • Master's (Preferred) or Bachelor's degree in Industrial, Mechanical, Manufacturing Systems, Biomedical Engineering, Biomedical Engineering, or related technical field with 6+ years of experience., • Certification in Six Sigma Black Belt (Preferred) or Green Belt Required Knowledge, Skills and Abilities • Demonstrated expertise in Design for Manufacturability (DFM) principles and tools., • Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis., • Proficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods., • Strong problem-solving skills with familiarity in DOE, SPC, and root-cause methodologies., • Experience with automated assembly systems, robotics, or high-volume manufacturing., • Knowledge of polymer processing, metal fabrication, laser welding or additive manufacturing., • Experience in Audit Readiness and Internal/External Audits with the various Regulatory bodies (FDA, TGA, PMDA, etc.), • Ability to communicate within the discipline and with others who are not technically trained, • Ability to prioritize tasks in a fast-paced environment. The salary range for this position is between $120k - $135k per year depending on experience and location. #LI-MV1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Senior Compliance Engineer is responsible for ensuring that Cardiac Assist electromechanical medical devices meet all applicable global regulatory, quality, and safety requirements throughout their lifecycle. This role provides technical leadership across product safety, electrical safety, design control compliance, labeling and safety markings, environmental/material compliance (RoHS/REACH), and global marketaccess requirements, ensuring products remain aligned with stateoftheart expectations. The Senior Compliance Engineer serves as a critical interface between Engineering, Quality, Regulatory Affairs, Supplier Quality, and Manufacturing, ensuring that product designs, sustaining engineering activities, and change initiatives remain auditdefensible, traceable, riskbased, and compliant across international markets. Job Responsibilities and Essential Duties • Lead compliance evaluations for new designs, design changes, sustaining engineering, and remediation activities., • Interpret and apply global standards including IEC 606011 series (electrical safety), IEC 6060118, IEC 60601112, EN 1789, GB 9706 series, UL/CSA, and other applicable international product and safety requirements., • Support development and verification of labeling, product safety markings, regional electrical requirements, and marketspecific compliance deliverables (EU MDR, FDA, China, LATAM)., • Conduct compliance impact assessments during design reviews, ensuring requirements, risks, verifications, and mitigations are aligned with global expectations., • Ensure compliance documentation is complete, consistent, and auditready (DHF/Technical File), including traceability, risk management, verification and validation records, and certification artifacts., • Provide guidance on environmental and material compliance (RoHS, REACH, China RoHS) and ensure supplier documentation meets regulatory expectations., • Support CAPA investigations that require compliance input, including evidence review, standards interpretation, and riskbased justification., • Maintain awareness of emerging regulatory changes and stateoftheart updates; drive integration into engineering processes and technical documentation, and identifying required retesting with recognized third party test labs., • Support global regulatory submissions (510(k), EU MDR Technical Documentation, and regional registrations) with compliance rationale and evidence., • Collaborate with Supplier Quality and Procurement to evaluate compliance of purchased components, including safetycritical and regulated materials., • Support internal and external audits, inspections, and technical inquiries, ensuring timely, accurate, and welldocumented responses., • Guide engineering teams in applying compliance principles early in product development to reduce downstream redesign and accelerate global approvals. Minimum Requirements • BS in Systems, Biomedical, Electrical, or Software Engineering with 5+ years of related experience, • MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 3-4+ years of related experience, • Demonstrated experience working with relevant medical device regulatory and productsafety standards (e.g., IEC 606011, ISO 14971, IEC/ISO environmental testing, labeling requirements, or international certification processes). Required Knowledge, Skills, and Abilities • Proven experience supporting compliance evaluation, maintenance, or certification of electromechanical medical devices., • Strong understanding of medical electrical safety (IEC 606011 series), product safety principles, risk management (ISO 14971), and global marketaccess requirements., • Working knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR and related regulatory frameworks., • Ability to interpret technical compliance reports (e.g., electrical safety, environmental compliance, risk controls, labeling/marking evaluations), identify gaps, and guide engineering teams toward compliant solutions., • Strong analytical and problemsolving skills with ability to apply riskbased decision making., • Excellent verbal and written communication skills, including preparation of auditready technical documentation., • Ability to work crossfunctionally and communicate effectively with engineers, quality, regulatory, suppliers, and certification bodies., • Strong organizational skills with the ability to manage multiple priorities in a regulated environment., • Ability to participate in and lead technical meetings, design reviews, and compliancefocused assessments. Salary range: $120k - 135k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Product Manager & Team Lead is a senior strategic leader within the Cardiovascular Surgery (CVS) business, responsible for high-level ownership of a broad and complex product portfolio. This role drives portfolio strategy, lifecycle performance, upstream marketing, voice of the customer interface, and cross-functional execution while ensuring alignment with business growth objectives and financial commitments. In addition to portfolio leadership, this position serves as the Team Lead for the Wayne Cardiovascular Surgery Product Management team and may directly manage Product Managers. The role provides mentorship, establishes operational rigor, and ensures excellence in product management execution within a highly regulated medical device environment. The individual must possess extensive medical device product management experience in highly regulated environments and demonstrated clinical marketing expertise. Job Responsibilities and Essential Duties • Hold high-level responsibility for a broad and strategically significant Cardiovascular Surgery product portfolio., • May directly manage a defined portfolio and/or individual Product Managers., • Drive full product lifecycle management from concept through commercialization and post-launch optimization., • Ensure portfolio alignment with strategic priorities and financial targets., • Optimize portfolio mix based on growth, profitability, clinical relevance, and competitive dynamics., • Serve as Leader for the Wayne Cardiovascular Surgery Product Management and PA Marketing/Training team., • Provide mentorship and coaching locally and across ACT product management teams., • Establish performance expectations and foster accountability., • May directly supervise and manage Product Managers., • Contribute to business strategy development and translate strategic objectives into actionable portfolio roadmaps., • Lead multi-year product planning aligned with innovation pipelines and commercial growth objectives., • Identify new market opportunities and unmet clinical needs., • Support Annual Operating Plan (AOP) and Long-Range Plan (LRP) development., • Provide oversight of major product management initiatives., • Lead governance for complex, high-impact programs including launches and lifecycle initiatives., • Manage risks, dependencies, and milestone adherence., • Develop and support robust business cases for capital investments (CAPEX)., • Track product and portfolio performance relative to approved CAPEX requests post-launch., • Monitor revenue, margin, ROI, and forecast performance., • Implement corrective strategies when performance deviates from projections., • Direct customer interface to understand customer experience and key requirements; resulting in strong messaging and customer strategy., • Lead market analytics initiatives across the portfolio., • Establish frameworks for competitive intelligence, pricing strategy, and market share analysis., • Leverage clinical marketing expertise to translate clinical evidence into compelling value propositions that drive the product management funnel activities., • Drive data-informed decision-making that enhances customer centricity., • Own creation and updates of all local product management procedures and support ACT standards., • Establish best practices for lifecycle management and launch excellence., • Ensure compliance with global regulatory and quality system requirements. Minimum Requirements • Bachelor's degree in Business, Engineering, Life Sciences, or related field required., • MBA or advanced degree preferred. Required Knowledge, Skills and Abilities • 10+ years of progressive medical device product management experience, • Extensive experience in highly regulated environments (FDA, EU MDR, global regulatory frameworks)., • Clinical marketing experience required, including surgeon engagement and clinical data translation., • Demonstrated success managing complex medical device portfolios., • Prior people leadership or team lead experience preferred. #LI-JF1 #LI-Hybrid Targeted salary range: $210,000- $245,000, depending upon experience and location +30% bonus target About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview As a Sr. Quality Engineer specializing in Quality Operations, you will be responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices. Job Responsibilities and Essential Duties • Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards., • Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement., • Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements., • Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability., • Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans., • Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations., • Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA)., • Track and monitor CAPA effectiveness to ensure issues are resolved and prevented., • Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee., • Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues., • Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy., • Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively., • Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity., • Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction., • Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards., • Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes., • Provide mentorship and guidance to new Engineers/Interns within the organization. Minimum Requirements • Bachelor's degree in engineering, Science, or other related field is required. ASQ, CQE, Six Sigma Green Belt or other applicable certifications are a plus., • A minimum of 7 years' experience in Quality or Engineering., • Experience in a medical device or pharmaceutical industry., • Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred., • Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred. Required Knowledge, Skills, and Abilities • Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans., • Project management and leadership experience is desirable., • Strong analytical and problem-solving skills., • Excellent communication and interpersonal skills., • Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R)., • Ability to work effectively in a cross-functional team environment., • Ability to review and understand technical standards and their requirements for products., • Proficiency in Microsoft Office Products such as Word, Excel, or equivalent software applications. Salary range: $115k - $120k plus 10% annual bonus #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Systems Engineer is a senior technical leader responsible for defining, architecting, and integrating complex medical device systems across hardware, software, firmware, and clinical use environments. This role provides technical direction across product development lifecycle phases, ensuring system-level requirements, risk management, verification, and validation activities meet regulatory and business objectives. The position partners closely with cross-functional teams to deliver safe, compliant, and high-quality products to market. The role also ensures alignment with usability engineering, reliability, and post-market surveillance expectations for medical devices as outlined by FDA and global regulatory bodies. As a subject-matter expert, the Principal Systems Engineer mentors engineers and influences technical strategy across programs. This role also assumes systemlevel product ownership for safety, performance, and compliance across the full lifecycle, including development, installed base, and postmarket use. The Principal Systems Engineer collaborates with Product Care, PostMarket Surveillance, and Field Action teams to ensure product issues are identified, assessed, and mitigated in alignment with regulatory expectations. Job Responsibilities and Essential Duties: System Architecture & Requirements Leadership (40%) Define and maintain system architectures, system-level requirements, and interface definitions across hardware, software, mechanical, usability, and clinical domains. Ensure traceability throughout the product lifecycle. Collaborate with Product Care teams to ensure system requirements remain aligned with field performance, complaint trends, and postmarket insights. Technical Integration & Risk Management (25%) Lead system integration activities, hazard analyses, and risk management in accordance with ISO 14971. Identify and resolve cross-domain technical issues and ensure alignment with regulatory expectations. Review and contribute to NCRs (NonConformance Reports), assessing systemlevel risk, technical impact, and the need for design or manufacturing actions. Provide system-level approval or input for NCRs requiring deviation or production impact decisions. Participate in investigations of product safety, performance, and compliance issues and support risk evaluations triggered by complaints, NCRs, or production trends. Verification, Validation & Regulatory Support (20%) Provide systems engineering leadership for verification and validation strategies, ensuring compliance with FDA, IEC, ISO, and global regulatory standards. Support design reviews, submissions, and audits. Support HF validation per IEC 623661 and FDA human factors guidance. Contribute to regulatory submissions (e.g., 510(k), PMA, technical files) by providing system-level documentation, architecture descriptions, risk traces, and verification summaries. Support Field Actions, Quality Holds, and CAPA processes when system-level issues require technical coordination. Coordinate crossfunctional data collection for complaints, investigations, PSUR inputs, and system-level risk analyses to ensure accurate evaluation and timely resolution of product issues. Technical Mentorship & Strategic Influence (15%) Mentor engineers, establish systems engineering best practices, and contribute to longterm technical roadmaps and platform strategies. Serve as a subject matter expert for Design Controls and systems engineering processes, guiding teams during audits and regulatory inspections. Act as a technical SME during audits related to postmarket surveillance, field actions, risk management, engineering change processes, NCRs, and product safety evaluations. Minimum Requirements • Bachelor's degree in engineering (Systems, Biomedical, Electrical, Mechanical, Software, or related field) required with 10+ years of related experience., • MS or PhD in Systems, Mechanical, Biomedical, Electrical, or Software Engineering with 8+ years of related experience, • 5+ years in medical devices or similarly regulated industries preferred., • Experience supporting postmarket investigations (complaints, NCRs, product concerns) and coordinating cross-functional data collection for safety and performance evaluations is strongly preferred. Certifications (Preferred) INCOSE Systems Engineering Certification (ASEP/CSEP) Project Management or Risk Management certifications a plus Training or certification in PostMarket Surveillance, CAPA, NCR processes, or Regulatory Compliance is desirable. Required Knowledge, Skills, and Abilities Deep knowledge of systems engineering methodologies, requirements management, and system architecture development Strong understanding of FDA Design Controls, ISO 13485, IEC 62304, IEC 60601, ISO 14971, and usability engineering principles Proven ability to lead cross-functional technical teams and resolve complex integration challenges Experience with requirements management and modeling tools (e.g., SOLIDWORKS, Polarion, Jama, SysML tools) Excellent analytical, documentation, and communication skills Ability to influence without direct authority and operate effectively in a matrixed organization Strong judgment, accountability, and attention to detail in safety-critical environments Knowledge of postmarket surveillance processes, field action coordination, complaint trend analysis, and systemlevel safety assessments. Familiarity with ECO/Change Control processes and ability to provide system-level technical assessments for design updates and NCR/Deviation evaluations. Salary Range:$150k - $180k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Principal Quality Auditor plays a vital role in leading and participating in internal and external audits within the medical device industry. This position ensures compliance with medical device regulations including, but not limited to ISO 13485, ISO 14971, 21 CFR Part 820. The auditor brings expert knowledge from prior roles leading audits and driving compliance improvements, risk management, and regulatory adherence. The position requires strong leadership in audit planning, execution, reporting, and follow-up, as well as mentoring audit teams and liaising with regulatory agencies. Job Responsibilities and Essential Duties • Lead and execute comprehensive audits of quality systems and processes to ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR, etc., • Participate in and lead FDA and Notified Body audits, including audit planning, execution, reporting, and corrective action follow-up., • Evaluate Quality Management Systems (QMS) for effectiveness, regulatory compliance, and risk management integration., • Assess and verify compliance with risk management standards (ISO 14971) and reporting requirements (21 CFR Part 803 Medical Device Reporting)., • Conduct audits on various QMS elements such as design controls, complaint handling, CAPA systems, supplier controls, and production processes., • Review and approve audit reports, findings, and CAPA plans to ensure timely and effective resolution of nonconformities., • Provide training and mentorship to internal audit teams to build auditor competency and ensure consistency., • Collaborate with cross-functional teams (Regulatory Affairs, QA, R&D, Manufacturing) to drive audit readiness and regulatory compliance., • Serve as a subject matter expert representing the company during regulatory inspections and notified body assessments., • Maintain up-to-date knowledge of regulatory changes and communicate their impact on quality systems and audit processes., • Facilitate internal audits and risk assessments to support continuous improvement and regulatory compliance readiness., • Support management review activities by providing audit findings and quality metrics relevant to compliance status. Minimum Requirements • Bachelor's degree in Engineering, Science, or equivalent; advanced degree preferred., • Minimum of 7 years of quality auditing experience in the medical device industry, including direct audit leadership at FDA or Notified Bodies preferred., • Deep expertise in ISO 13485, ISO 14971, and 21 CFR Part 820 regulations., • Certified Quality Auditor (CQA) or equivalent ISO 13485 Lead Auditor Certification preferred., • Proven experience in planning, conducting, and leading regulatory audits and inspections., • Strong knowledge of risk management principles and medical device regulatory reporting requirements., • Excellent ability to analyze complex quality systems and processes and identify compliance gaps., • Strong communication skills to effectively present audit results and influence corrective action implementation., • Proficiency with quality management software tools and Microsoft Office. Salary range: $155k - $165k #LI-LG1 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: • Health, Dental, and Vision insurance benefits, • 401k plan with company match, • Paid Time Off, • Wellness initiative & Health Assistance Resources, • Life Insurance, • Short and Long Term Disability Benefits, • Health and Dependent Care Flexible Spending Accounts, • Commuter Benefits, • Parental and Caregiver Leave, • Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Responsibilities: Inspect cylinders and perform safety checks; Fill cylinders by pressure and weight while ensuring compliance; Operate forklift and warehouse equipment; Maintain records to regulatory standards (DOT, FDA, OSHA); Label cylinders accurately.

Job DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Schedules and monitors daily operation of department based on projected client demands., • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices., • Approval of investigations and documentation of non-confirming events and OOS., • Recommends process improvements to achieve greater efficiency within the department and between sites., • Participates in department and cross functional meetings., • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness., • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Direct reports: QC Analysts (Approximately 8-10 reports), • Other duties as assigned.REQUIREMENTS, • BS degree in Science or relevant field;, • 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent., • Strong knowledge of FDA and EU regulatory standards. cGMP experience required., • Strong knowledge of analytical test methods and philosophies., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office and LIMS, • Competencies/Candidate Profile, • Acts decisively, • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively., • Builds and maintains relationships, • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders., • Communicates effectively, • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback., • Fosters continuous improvement and innovation, • Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies., • Fosters integrity and honesty, • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically., • Supervises and manages performance, • Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues., • Manages projects and functions, • Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication., • GxP/GDP TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. 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.

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. 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.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.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.

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.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.

Job Description Sr. Principal Statistics needs 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Sr. Principal Statistics requires: • SAS, ICH guidelines, CDISC data structures, FDA guidelines, SAP preparation, TFL shells, CRF review, database design review, edit check specifications, sample size calculation, analysis dataset validation, CRO oversight, • Education: Ph.D. or MS in Statistics or Biostatistics, • Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience, • Excellent knowledge of SAS computer package, • Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines, • Excellent organizational skills, time management, and ability to meet established deadlines., • Excellent communication and interpersonal skills to effectively interface with others, • Exceptional interpersonal skills and problem-solving capabilities, • Ability to work independently and collaboratively, • Ability to provide leadership for the CRO statisticians and statistical programmers Sr. Principal Statistics duties: • Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc., • Review CRF, database design, and edit check specs, • Review study quality surveillance plan and monitor study conduct, • Prepare and/or review SAP, TFL shells and specifications for variable derivation, • Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables, • Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics, • Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents, • Perform other ad-hoc statistical activities as needed, • Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming, • Participates in monitoring CRO activities and reviewing CRO deliverables

Job DescriptionPosition Description: Dr. Praegers was founded in 1992 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 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.

Job Description Auto-Chlor is now hiring an Electrical Engineer-Equipment Design to lead our engineering development initiatives. We’re looking for a leader who will contribute to our “People First” culture. This position would work in-office full-time at our facility in MEMPHIS, TN. What’s in it for you? RELOCATION ASSISTANCE OFFERED We understand that great talent can come from anywhere. That's why we offer: • Up to 60 days of temporary housing, • Reimbursement for moving and travel expenses, • Support with general relocation needs, • A people first culture where contributions and collaboration are encouraged and celebrated., • A competitive salary up to $150k annually with an excellent benefits package., • Ongoing wellness initiatives to improve your health and well-being. What are some of the day-to-day responsibilities? • Develops and implements solutions for dishwasher and dispensing innovation projects, including both new equipment development and existing equipment innovation. Projects vary in duration from two months to over a year based on Project Brief requirements., • Administers regulatory compliance with agencies such as NSF, CSA, UL, BOCA, ASSE, UPC, and Federal, State, and Local authorities. Provides support to the field sales team on regulatory issues, with an emphasis on maintaining customer equipment operation without disruption to business., • Provides technical support to field sales team, contractors, consultants, engineers, and architects., • Develops and manages technical documentation for design control and field use. Requirements: • Bachelor of Science in Engineering Degree or comparable years of work experience., • 5-10 years of electrical and electronic design experience, along with experience working with regulatory agencies. Experience in the commercial appliance industry is preferred., • Embedded Software/hardware design, • Knowledge of codes and standards for plumbing, sanitation, electrical, and building (NSF, CSA, UL, BOCA, ASSE, UPC, FDA), • Electrical/electronic circuit design, • CAD Modeling – Autodesk Inventor Preferred Location: 746 Poplar Ave Memphis, TN 38105

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Manager. This individual will have the responsibility for Quality aspects related to Quality Systems in the packaging facility. The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada). Overall Responsibilities For Quality Operations And Initiatives, Including • Quality Assurance management:, • Documentation control (master batch record, specification and method), • Batch record review and product disposition, • Investigations, complaints, deviations, CAPAs, APRs, • Production and Pharmaceutical Development support, • APRs, GMP training and SOP review, • Validation / qualification documentation review and approval, • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site, • Develop, maintain, and enhance training programs and systems, • Driving key compliance initiatives such as, Training Program Enhancements, Quality Documentation System Enhancements, other identified initiatives., • Must be able to move about the facility, • Experience with FDA Audit, • Extensive knowledge of US and EU current Good Manufacturing Practices, • Experience with a CDMO would be preferable, • In collaboration with the Quality Assurance team, the Quality Assurance Manager will be responsible for: i). Quality Compliance management: ii). All audits, internal, external - regulatory, client and vendor iii). Vendor management program iv). QA Agreements with clients & contractors v). License renewals Company DescriptionWe are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..We are a pharmaceutical packaging company looking for someone who is proactive and will to learn and grow..

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.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.

Job DescriptionJOB DESCRIPTION:The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. RESPONSIBILITIES:Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. Review CRF, database design, and edit check specs Review study quality surveillance plan and monitor study conduct Prepare and/or review SAP, TFL shells and specifications for variable derivation Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables Provide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statistics Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents Perform other ad-hoc statistical activities as needed Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming Participates in monitoring CRO activities and reviewing CRO deliverables Other duties as assigned QUALIFICATIONS:Education: Ph.D. or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines Excellent organizational skills, time management, and ability to meet established deadlines. Excellent communication and interpersonal skills to effectively interface with others Exceptional interpersonal skills and problem-solving capabilities Ability to work independently and collaboratively Ability to provide leadership for the CRO statisticians and statistical programmers PHYSICAL AND MENTAL REQUIREMENTS:Ability to multitask Adapts to change Maintain composure under pressure Ability to follow verbal or written instructions and use of effective verbal communications Adapts change, adjust change and grasps information quickly Examine and observe details

Job Description Assistant Clinical Research Coordinator Title: Assistant Clinical Research Coordinator Location: Secaucus, NJ, onsite Reports to: Manager of Clinical Operations. Full-time/ Hourly Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position/Job Summary: The Assistant Clinical Research Coordinator Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol. Roles & Responsibilities: • Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures., • Develops a strategy for implementing study procedures in compliance with the study protocol., • Performs study procedures (e.g., obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators., • Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness., • Assists the clinic team in transcribing study data from source documents to sponsor designated electronic case report forms., • Resolves data queries in conjunction with the sponsor., • Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor., • Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the sponsors and IRB., • Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator., • Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines., • Assists in the screening of research subjects to evaluate their eligibility for a clinical study., • Creates and performs QC procedures., • Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators., • Other assigned. Education, Experience & Skills Required: • At least 6 months’ experience supporting clinical research study conduct., • Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred., • Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint., • Strong written and verbal communication skills., • Effective time management and organizational skills., • Attention to detail and accuracy in work., • Knowledge of applicable protocol requirements. Salary: $25.00/hour Benefits: • 401k Employer Match with immediate vesting, • Vision Insurance, • Medical and Dental Insurance with multiple coverage options, • FSA (Medical, Dependent Care, and Commuter), • Short Term Disability, • Long Term Disability, • Life Insurance, • Generous Paid Holidays and PTO Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Job Description Salary: $95,000.00 - $100,000.00 Other Forms of Compensation: N/A What makes FLIK click What makes FLIK click? Our people. The decisions, actions and attitudes of our associates earn the trust and loyalty of our clients every day. We know how to pick them and we know how to grow them. It starts with hiring people who share our passion for food and hospitality. Once we find the right talent, we encourage, value and recognize their contributions. We keep our people renewed, excited and engaged by providing hands-on training and educating them about the latest trends. We give them a stake in successfully raising the bar. Our people love what they do and they love sharing their passion. Join our team and see the FLIK difference. Where a job isn’t merely a job but the start of a career where you can flourish. Job Summary Job Summary: The Quality Assurance Manager is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls for Human Food. A strong background in manufacturing, quality assurance and strong understand of FSMA is a must. Key Responsibilities: • Contributes to development and execution of product food safety and quality programs to support the organization’s goals of operational excellence, customer/client satisfaction, financial performance, market leadership, and preferred employer., • Responsible for developing and on-going maintenance of the Food Safety Plan. Must be able to identify deficiencies and implement new strategies., • Ensures all HACCP, GMP’s, sanitation preventive controls, supply chain preventive controls and all other prerequisite food safety standards are met according to USDA, FDA, FSIS, FSMA and corporate requirements., • Must have extensive knowledge of the facilities process flow and engage personnel in all areas of food safety and quality within the flow., • Manages Allergen Preventive Controls Program ensuring accurate allergen labeling on finished food products and prevention of allergen cross contact., • Manages the written recall program., • Ensures complete traceability of incoming raw materials and finished product while managing lot code tracking., • Ensures labeling programs is accurate in accordance with allergens, ingredients and nutritional information., • Oversees all food safety audits conducted by government and third party agencies., • Responds to customer safety and quality concerns as needed. Preferred Qualifications: • At least 6 years of directly related experience required in Quality Assurance and Food Safety manufacturing role., • Experienced in prepared foods manufacturing a plus., • HACCP program development and FSMA is a must., • HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must., • Regulatory experience preferred, with a clear understanding of local health department regulations, standards, and inspection expectations., • Flexibility to travel to support other locations, including participation in regulatory inspections, audits, and operational support visits., • Experience with corrective action plans (CAPs) and complaint investigations, including documentation, root cause analysis, and follow‑up., • Strong understanding of required third party audit and GFSI audit scheme programs and standards., • Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice., • Experience developing and motivating personnel., • Track record of food safety/QA success in any of the following focus areas a plus: meat, poultry, seafood, processed foods, distribution, proprietary/private-label product development and/or monitoring., • B.S. degree in food technology, food science, or related curriculum and/or experience required., • Ability to function effectively within a fast-paced, diverse and evolving corporate culture is necessary., • Proficient in Microsoft Office applications and ability to learn various software and web-enabled programs., • Must be a strong, persuasive communicator and coach, with the ability to relate to other professionals, peers, and field operators, both technical and non-technical., • Strong data management, reporting, and technical writing skills. Apply to Flik today! Flik is a member of Compass Group USA Click here to Learn More about the Compass Story Associates at Flik Hospitality are offered many fantastic benefits. • Medical, • Dental, • Vision, • Life Insurance/ AD, • Disability Insurance, • Retirement Plan, • Paid Time Off, • Holiday Time Off (varies by site/state), • Associate Shopping Program, • Health and Wellness Programs, • Discount Marketplace, • Identity Theft Protection, • Pet Insurance, • Commuter Benefits, • Employee Assistance Program, • Flexible Spending Accounts (FSAs), • Paid Parental Leave, • Personal Leave Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here or copy/paste the link below for paid time off benefits information. https://www.compass-usa.com/wp-content/uploads/2023/08/2023WageTransparencyFlikHospitality.pdf Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. Certain positions may require Florida Level 2 background screening. Details: https://info.flclearinghouse.com/ Applications are accepted on an ongoing basis. Flik maintains a drug-free workplace. Req ID: 1530187 Flik Hospitality Group Steven Goldberg [[req_classification]]

Job DescriptionThis is a temporary 6-month contracted W2 position. The pay range for this position is $70-$85/hr (depending on prior experience) Job Functions: • Applies expertise as an emerging authority in the mechanical engineering discipline., • Conceives and develops solutions to difficult analytical and pneumatic/mechanical/electrical design problems., • Participates in establishing system or component design objectives and writes portions of complex specifications and engineering reports., • Reviews and helps to develop product specifications, • Conducts conceptual design studies using MCAD and other applicable design tools. Collaborates with other engineering functions, • Develops prototype hardware using internal manufacturing resources and outside vendors, • Tests product to verify that designs meet specification requirements such as environmental, regulatory and safety requirements, • Generates documentation supporting the design, • Provides training, technical advice and guidance to junior engineers. Guidance may be technical or project related as Project Leader or Lead Engineer of small to medium projects. Required Knowledge, Skills and Abilities: • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Familiarity with dimensioning and tolerance, thermal and structural analysis, and vibration testing/analysis, • Intermediate knowledge of FDA, IEC and UL standards relating to medical electronic equipment, • Strong technical and analytical ability, verbal and written communication skills, ingenuity and creativity, interpersonal and project management skills, • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes, • Familiarity and the ability to operate basic shop equipment such as a drill press, lathe, milling machine, brake and shear Minimum Requirements: • BSME or MSME and a minimum of 10 years of related experience in design/product development of electro pneumatic assemblies including technical supervision of sub-projects, • Formal training in basic and advanced topics in Solid Works is strongly preferred, • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat, • Advanced proficiency with SolidWorks, MCAD/CAE software and database management software preferred, • Advanced proficiency with Microsoft Visio and Microsoft Project preferred Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com. Powered by JazzHR YICfO1XHEv

Job DescriptionPosition Description: Dr. Praegers was founded in 1994 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: This position is responsible for supporting and maintaining the Quality Management System (QMS) for clinical research activities conducted in the U.S., including SOP lifecycle management, document management system administration, user access control, TMF support, and operational assistance for local staff. The role works closely with the Associate Director and collaborates with cross-functional teams in the U.S. and Japan Headquarters to ensure compliance with applicable regulations (FDA, ICH-GCP) and internal standards. Essential Duties and Responsibilities: SOP Management • Maintain and update SOPs and controlled documents in accordance with internal procedures and regulatory requirements., • Coordinate SOP revisions, reviews, approval workflows, and periodic updates., • Track and manage SOP training compliance for local staff/Expats. Document Management System Administration • Serve as system administrator for the Document Management System (e.g., user provisioning, access rights, permission changes, issue troubleshooting)., • Provide onboarding and ongoing training to users on document management processes and system usage., • Ensure compliance with established document governance standards. TMF (Trial Master File) Support • Provide operational support for TMF processes, including quality checks, filing accuracy, and document completeness., • Coordinate with CROs and internal teams to ensure TMF inspection readiness., • Assist in implementing TMF standards, filing plans, and quality review processes. Local Staff Operational Support • Act as a primary point of contact for U.S.-based team members for QMS- and documentation-related matters., • Provide guidance and troubleshooting on SOP interpretation, documentation workflows, and compliance expectations., • Support audits and inspections by preparing relevant documentation and coordinating responses. Cross-Functional & Global Collaboration • Collaborate with Japan Headquarters teams to ensure alignment of quality and documentation standards., • Participate in global or regional meetings related to QMS, SOPs, and document management., • Contribute to harmonization projects for global SOPs, templates, and processes. Future or Expanded Responsibilities (as organizational needs evolve) • Support clinical team regarding vendor oversight processes, including documentation tracking and compliance checks., • Provide operational support to study teams using Veeva applications (e.g., Vault, eTMF, Quality Docs), • Participate in broader Quality Management System initiatives as needed. Supervisory Responsibility • No direct reports; may guide junior staff or contractors. Qualifications: Required • Experience in clinical research, clinical operations, quality, or document management within the pharmaceutical/biotech/CRO industry., • Strong understanding of FDA regulations and ICH-GCP guidelines., • Hands-on experience with document management systems (eTMF, CTMS, DMS, or similar)., • Excellent communication skills and ability to work in a multicultural, global environment., • Strong organizational skills and ability to manage multiple priorities simultaneously., • Ability to proactively identify issues, propose solutions, and support continuous improvement. Preferred • Experience managing SOP lifecycle processes or QMS operations., • Knowledge of TMF structure, filing expectations, and inspection readiness., • Experience supporting audits/inspections., • Japanese language skills a plus (not required)., • Experience with Veeva Vault (eTMF, QualityDocs, or CTMS), • Experience supporting vendor management, Issue/Risk Management Education: • Bachelor’s degree in a life science, healthcare, or related field., • 3–5+ years of relevant industry experience. Compensation And Benefits: NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $110,000 to $140,000 actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until June 30, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.

Job DescriptionSr. Manager/ Associate Director Document & Change ManagementAllendale, NJ The Senior Manager Documentation & Change Management will assist with the overall leadership and implementation of global Document Management and Control and the Change Control Management program designed to comply with applicable laws and regulations. This position has accountability for development and oversight of global quality documents, the structure of the program, and the design, implementation and continuous improvement of electronic document management systems. This position also has responsibility for oversight of the regional Change Management system and accountability for the design, implementation, administration, and continuous improvement of the electronic change management system. • Responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures., • Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival., • Maintains the global Quality Manual and global Quality Standards, and any associated global policies, reports, or documents., • Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning., • Engages process owners and SMEs to ensure quality standards are appropriately defined, implemented, and/or updated to include current regulatory strategy and are contemporaneous with industry standards., • Leads the development of reporting on quality standards implementation across all functions., • Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution., • Partners, educates, and collaborates with Documentation Control, QA, and SOP authors/owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule., • Business process owner for the electronic documentation management system. Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system., • Manages the document change request system at the global and regional level and provides guidance at the site level., • Provides support during internal and external audits, including Regulatory Health Authority inspections., • Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.Change System Management:, • Serves as subject matter expert for the regional change control system and associated requirements., • Develops standards and guidelines for change control inputs and requirements needed to support change control requests., • Oversees and administers the Change Control Board for regional/global Change Control requests and provides guidance at the site level., • Leads the electronic change management governance process and serves as administrator to the e-system., • Interfaces with IT as the Business Process Owner for the electronic change management system. Develops and prioritizes system enhancements and added functionality based on business need., • As needed, works Quality Assurance and functional area representatives or responsible change owners to develop change management strategies., • Develops and provide reports on change management process and progress for global dashboard., • This role may have direct reports. The role also functions as an individual contributor role in a heavily matrixed environment., • Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates., • Phone conferences outside of normal working hours is required in order to interact with global counterparts., • Travel is required at approximately 15%.REQUIREMENTS, • BA/BS in the Life Sciences is required. MS degree in Life Sciences a plus., • 7-10+ years experience in Document Management and Control and 3-5 years experience in Change Management in FDA-regulated, GxP-related Industry is required., • Comprehensive knowledge of document control principles, data integrity principles, and good documentation practices a must., • Demonstrated experience with implementation and management of electronic document management systems required., • Working knowledge of electronic change management systems or e-QMS required., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Ability to drive Quality projects for continuous improvement., • Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required., • Knowledge of European and Japanese Health Authority requirements is a plus., • Ability to work independently with minimal supervision is required., • Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, and auditors. Proven interpersonal skills with face to face and remote teams., • Position will be filled at level commensurate with experience., • Strong computer skills are required., • Excellent oral, written, and verbal communication skills are required.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.

Job Description Join Our Team at Bergen New Bridge Medical Center! We are dedicated to providing high-quality, compassionate care to our diverse community. As a leading healthcare provider, we offer a supportive and inclusive work environment. If you’re passionate about making a difference and thrive in a collaborative setting, Bergen New Bridge Medical Center is looking for a Mammography Technologist. Job Duties Performs and obtains high quality mammograms on all patients (i.e. In-Patients, Clinic or Private Outpatients); recognizes the need for and utilizes radiation protection measures as appropriate in accordance with departmental policies. As required, transports patients to and from mammography rooms. Assists the Radiologist with needle localizations. Properly utilizes all mammography equipment permitted within the scope of their license and within the realm of their training. Assessment, treatment and patient care responsibilities are delivered with a knowledge of patient growth and development and are appropriate to the ages of the patients served. Ability to perform and maintain quality management as required by the FDA and MQSA. Customer Service: respect, flexibility, knowledge, confidence, professionalism, pleasant attitude, patience and helpfulness. All responses should be timely, professional, caring, and respectful in accordance with Customer Service Performance expectations Maintains established departmental policies and procedures, objectives, quality assurance program, safety, environmental, and infection control standards. Assesses gaps in policies and procedures, and create necessary policies and procedures to fulfill these gaps. Understands and adheres to the Medical Center’s Code of Conduct. Familiar with the Medical Center’s Mission, Vision, and Values Statements. OTHER JOB DUTIES Develops all X-rays when required. Provides patient comfort (e.g., bedpans, blankets) as required. Performs required clerical work when necessary to maintain patient records. Maintains a clean and orderly environment to include; Mammography room and equipment, and Mammography processor and dark room. Informs appropriate personnel when equipment is in need of repair. Fulfills all continuing education requirements specified by regulatory agencies and Medical Center standards. Performs other related duties as required. BASIC COMPETENCIES Education/Licensure Graduation from an AMA approved School of Radiologic Technology; ARRT or Registry eligible. Current NJ license as a Licensed Radiologic Technologist. Mammography registry. American Heart Association Heart saver CPR/AED certification. Experience None Skills Good interpersonal skills. Speaks, reads and writes English to the extent required by the position. JOB SETTING/PHYSICAL DEMANDS Diagnostic Imaging Department; contact with staff, patients. Lifts, positions and/or transfers patients. Frequent prolonged standing. Lifts/moves x-ray equipment. Protective clothing worn: gloves, gown, lead apron. Salary commensurate with experience within posted range. $38.46-$43.07 DIFFERENTIALS EVE/NIGHT $2.40/ WEEKEND $1.75 We provide a comprehensive benefits package, including a competitive medical, dental, and vision plans. We prioritize work-life balance with a generous time off policy that includes ample vacation days, personal time, sick leave and nine paid holidays. Additionally, we are committed to the personal and professional growth of our employees, offering robust tuition reimbursement and continuing education programs to help support our employees ongoing development. Company DescriptionBergen New Bridge Medical Center, a clinical affiliate of Rutgers Biomedical and Health Sciences, is a 1,070 bed hospital located at 230 East Ridgewood Avenue in Paramus, NJ. Founded in 1916 to treat patients with contagious diseases, the medical center has grown to become both the largest hospital and licensed nursing home in New Jersey and the fourth-largest publicly-owned hospital in the nation. A safety net facility, Bergen New Bridge Medical Center, renamed in October 2017, provides high-quality comprehensive services including long term care, behavioral health care, substance abuse treatment, and acute care to the greater Bergen County community. The medical center, including its Long Term Care Division, is fully accredited by The Joint Commission. With 323 behavioral health beds and 84 medical detox beds, Bergen New Bridge Medical Center is one of the largest medical facilities providing a continuum of care for those in need of behavioral health and/or substance abuse treatment. Please apply on our website: https://www.newbridgehealth.org/careers/Bergen New Bridge Medical Center, a clinical affiliate of Rutgers Biomedical and Health Sciences, is a 1,070 bed hospital located at 230 East Ridgewood Avenue in Paramus, NJ. Founded in 1916 to treat patients with contagious diseases, the medical center has grown to become both the largest hospital and licensed nursing home in New Jersey and the fourth-largest publicly-owned hospital in the nation. \r\n\r\nA safety net facility, Bergen New Bridge Medical Center, renamed in October 2017, provides high-quality comprehensive services including long term care, behavioral health care, substance abuse treatment, and acute care to the greater Bergen County community. The medical center, including its Long Term Care Division, is fully accredited by The Joint Commission. With 323 behavioral health beds and 84 medical detox beds, Bergen New Bridge Medical Center is one of the largest medical facilities providing a continuum of care for those in need of behavioral health and/or substance abuse treatment.\r\n\r\nPlease apply on our website: https://www.newbridgehealth.org/careers/

Job DescriptionTitle: Stability Coordinator Reports to: Manager, Quality Systems/Validations Department: Quality Assurance Organizational Relationships: Batching & Filling/Assembly areas, Customer Reps, Customers, Approved Testing Labs and Warehouse/Shipping personnel. Responsibility Summary: The Stability Coordinator is responsible for managing all aspects of stability sample preparation, submission, and documentation in compliance with approved protocols and cGMP standards. Key duties include coordinating with testing laboratories, maintaining accurate logs, monitoring stability chambers, and preparing detailed reports for quality review. The role ensures timely tracking of test results, supports regulatory requirements, and promptly reports any out-of-specification findings to the Quality team. Responsibilities: The Stability Coordinator is responsible for supporting the company's business events through a variety of tasks, including: • Reviews batch and finished product stability samples using approved stability protocol, current product specifications and sample submission forms., • Prepares stability samples and submission documents., • Co-ordinates with testing labs as required., • Facilitates maintenance of awareness and compliance with cGMP and safety regulations in production, manufacturing and related areas., • Maintain current logs (with sent dates, result due dates, result receipt dates, etc) for all stability samples to support approved protocols., • Daily / Periodic monitoring and documentation of (a) Walk-in; (b) Reach-in; and (c) Freeze/Thaw chambers and their parameters such as temperature and humidity, PM, calibration, Water supply, etc., • Must be familiar and current with Englewood SOP 1-050 (Operating, Maintaining and Monitoring of Stability Chambers); SOP 1-033 (Stability Testing for Drug Products) and Englewood Lab Quality Form, EQF 206, 207, 022 and EQF 121., • Prepares stability sample submission documents to cover long term, accelerated, freeze-thaw, intermediate (if applicable), preservative challenge test (PET)., • Maintains stability reports including compatibility, analytical method validation, and PET., • Assemble on-going, in-progress, and completed reports for review by QC Manager or designee., • Maintain tracking logs and correspondence to support stability sample submission to approved labs and for customer evaluation., • Immediately notify Quality personnel if out-of-specification (OOS) is observed in stability test results., • Periodically review stability logs for completeness., • Ensure that only most current versions of product specifications are used for product testing by the approved labs., • Ensure on-time submission of samples and receipt of results/customer approvals., • Maintains awareness and compliance with US FDA, ICH Stability, GMP and safety regulations in performing job duties., • All other functions and duties as may be assigned by immediate supervisor. Qualifications: • Associate’s degree (2-year college degree) required., • Experience in cosmetic, device, food or pharmaceutical inspection process preferred., • Good math skills., • Ability to read and interpret internal and external sampling plans and effectively report results., • Effective communication skills with internal and external customers., • Ability to lift and carry up to 10-15 pounds. This position is Full-Time, Onsite in Totowa, New Jersey, five days per week in the office (9:00AM - 6:00PM) Compensation & Benefits: The approximate pay range for this position is $50,000 - $60,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, Vision, Life, • PTO, • Special Paid Leave for employees’ personal events, • Company Paid Holidays, • 401(k) employer match, • Year-End Gift Powered by JazzHR CsigK53ac5

Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Regional Sales Director is a first-line sales leadership role responsible for building, developing, and leading a high-performing specialty sales team supporting the launch and growth of an innovative mental health therapy. This leader will drive regional execution of commercial strategy by partnering with certified treatment centers, psychiatrists, and integrated care systems while ensuring alignment with regulatory, safety, and patient-access frameworks. The Regional Sales Director will play a critical role in shaping a new therapeutic category, and creating a culture of integrity, collaboration, and patient-centricity. Location: Remote in New York (New York, NY, Philadelphia, PA, Newark, NJ). Reports to: Director, National Sales. Roles and responsibilities (Include but are not limited to): • Recruit, onboard, and lead a team of Territory Account Managers, • Foster a high-accountability, psychologically safe culture that promotes coaching, development, and collaboration, • Set clear expectations and performance standards aligned with company launch objectives, • Drive successful regional execution of the commercial launch strategy and identify opportunities to expand the treatment ecosystem, • Ensure field readiness around clinical data, patient identification, treatment protocols, and site-of-care logistics, • Foster strategic relationships with psychiatrists, treatment centers, behavioral health systems, academic centers, and Key Opinion Leaders (KOLs), • Partner cross-functionally with Medical Affairs, Market Access, Training, Patient Support, etc., • Provide field insights to inform brand strategy and launch optimization, • Analyze regional performance metrics and develop action plans to drive results, • Manage regional budgets, forecasting, and territory alignment, • Conduct regular field coaching to strengthen clinical selling skills and consultative engagement with mental health providers Candidate Profile: • Bachelor's degree required (advanced degree preferred), • 8-10+ years of pharmaceutical or biotech sales experience, • 5+ years of first-line sales leadership experience, • Demonstrated success launching specialty or neuroscience therapies, • Experience in psychiatry, CNS, or behavioral health markets, • Experience launching therapies requiring site certification, REMS, or specialized administration models and/or a background working with IDNs, academic medical centers, and specialty treatment sites, • Experience building teams in startup or pre-launch biotech environments 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$180,000—$230,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.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.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.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.

Job DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease 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.

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. 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.