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Job Description Inspiring Physicians, a leader in the field of aesthetic body contouring and natural fat transfers seeking additional representation in specific markets. Our device, has been proven, to be the fastest, safest, and most efficatous device on the market while providing revenues associated with a surgical procedure. In addition,, we have entered into a collaborative agreement with a FDA cleared lab , to both bank and replicate stem cells for a multitude of applications. This is a capital sale, $250,000, with commissions of 10%. Your role is to indentify the prospect we do all the rest do no demos or training etc. If you are a "hunter" we encourage you to submit a resume for review Company DescriptionMANUFACURER AND WORLD WIDE DISTRIBUTORMANUFACURER AND WORLD WIDE DISTRIBUTOR

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 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 Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job Description Clinical Research Nurse (per diem) Title: Clinical Research Nurse (per diem) Location: Secaucus, NJ (On-site required) Reports To: Executive Medical Director and Principal Investigator Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, 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 Summary: We are seeking a licensed and detail-oriented Clinical Research Nurse in support of clinical trials conducted at Frontage Clinical Services. in support of clinical trials conducted at Frontage Clinical Services. responsible for working under the guidance of the Investigators; Management, Study Coordinator and Supervisor, to perform study procedures required in clinical studies conducted on behalf of sponsors at the Frontage Clinical Services site in Secaucus. Responsibilities: • Assist Clinical Study Coordinators in any task as needed., • Administer Medications (including IV administration route) per doctor’s and protocol instructions., • Perform study procedures (e.g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators, Director, Associate Director, and Clinical Research Coordinators., • Record study data in the source documents. Evaluate and review study data to ensure accuracy and completeness., • 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., • Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor., • Responsible for maintaining emergency medication in the crash cart., • Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator., • Assists in the screening of research subjects to evaluate their eligibility for a clinical study., • Creates and performs QC procedures., • Assists in the reconciliation of IPs and maintaining accountability., • Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (e.g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.), • Bachelors in Science in Nursing., • Registered Nurse in the State of New Jersey, • Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Services and sponsor personnel., • 1-3 years' experience in clinical research is desirable. Knowledge of FDA regulatory requirements is necessary, or mandatory on-job training will be required. Salary and Benefits: Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc. 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 Title: Radiopharmaceuticals & GCP Compliance QA Auditor Location: Paramus, NJ Job Type: Contract Work Type: Onsite Shift: 9.00AM-5.00PM Pay Rate: $45.00-50.00/ Hourly Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Job Description: Summary: • The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance., • This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment., • The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits., • This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials., • The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates., • The ideal candidate will have extensive GCP experience., • This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies., • They are based in Northern New Jersey and require the candidate to be on-site., • 5+ years of pharmaceutical experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections.

QC Manager – Fairfield, NJ Summary: The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed Responsibilities: • Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives, • Train and develop analysts, • Formulate, document, and maintain quality control standards and on-going quality control objectives, • Schedule workload to meet release objectives and deadlines, • Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines, • Author analytical methods and SOPs, • Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments, • Develop specifications and analytical methods as required, • Develop analytical methods to support product development projects, • Prepare analytical method validation protocols and reports, • Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed., • Manage the outsourcing process of testing to contract laboratories, • Ensure lab safety and manage chemical inventory, • Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations, • Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements, • Audit the work of QC Analysts, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management Experience Requirements: • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with GC sample preparation and testing, • Knowledge of USP Monograph testing, analytical method development & validation, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes, lab safety and GDP. Computer Skills: • Proficiency in Microsoft Word, • Proficiency in Microsoft excel, • Proficiency in Empower 3 Other requirements: • Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory., • Able to perform complex mathematical problems, • In depth knowledge of all laboratory equipment, practices, and procedures, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English, • Able to lift 25 pounds, • Able to stand for extended periods Hours: • Standard: 8:30 AM to 5:00 PM, Monday through Friday, • Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

QA/QC Director – Fairfield, NJ Summary: The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements. Responsibilities • To ensure that the production facility is operating at a high operational and compliance standard., • Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives, • Monitor each department’s operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company’s clients., • Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service., • Ensure that deadlines are met, • Train and develop colleagues, • Assist employees to solve problems, using quality management techniques, • Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees, • Help to promote the implementation of quality systems throughout the company, • Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference, • Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera, • Other duties assigned by Management Education: • Bachelor’s degree in a scientific discipline with a minimum of 10 years’ experience in quality management Experience Requirements: • Experienced with liquid manufacturing and packaging of Rx products., • Experience with Empower 3, • Experience working in an FDA regulated environment, • Experience with ANDA and NDA submissions, • Experience with validations of processes, cleaning, analytical methods, facilities and equipment, • Knowledge of CFR & ICH Regulatory Guidelines, • Knowledge of cGMP processes and GDP. Computer Skills: • Microsoft Word, • Microsoft Excel, • Has significant technical knowledge of quality management principles., • In depth knowledge of all laboratory equipment, practices, and procedures, • Ability to think logically and independently, • Demonstrated managerial abilities, • Problem analysis, solving and resolution skills, • Has excellent oral and written skills, • Has excellent interpersonal skills, • Is self motivated, • Has a very high attention to detail, • Has a positive attitude, • Must speak, read, and write in English

A leading global biopharmaceutical organization is seeking a seasoned Executive Director of Global Regulatory Strategy to lead regulatory initiatives across a diverse portfolio of innovative therapies. This is a high-impact, hands-on leadership role ideal for a strategic thinker with deep regulatory expertise and a passion for advancing global health. Responsibilities: • Provide strategic regulatory leadership for global development programs and marketed products across designated therapeutic areas., • Lead and mentor a team of regulatory professionals in the development and execution of global regulatory strategies., • Serve as the senior regulatory representative on cross-functional project teams throughout the product lifecycle., • Advise executive leadership on U.S. and international regulatory matters, ensuring alignment with evolving global standards., • Oversee planning and execution of regulatory agency interactions, including meetings with major health authorities (e.g., FDA, EMA, PMDA)., • Actively participate in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and development of corrective actions., • Support regulatory inspections and audits, including response development and implementation of corrective actions., • Monitor and interpret global regulatory trends, providing strategic insights and direction on emergency policy & regulatory intelligence., • Drive continuous improvement in regulatory processes and team performance., • Manage timelines, budgets, and resource planning for regulatory programs., • Contribute to global regulatory policy initiatives and cross-functional governance committees. Qualifications • Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, or equivalent) preferred., • Minimum of 15 years of industry experience, including at least 10 years in regulatory affairs within the biopharma sector., • Proven leadership experience managing regulatory teams and complex global submissions., • Demonstrated success in leading regulatory strategy for major marketing applications (e.g., NDA, BLA, MAA)., • Strong track record of engagement with global regulatory agencies (FDA, EMA) and successful negotiation of regulatory pathways., • Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada)., • Strategic mindset with the ability to navigate ambiguity and make informed decisions., • Excellent communication and presentation skills, with the ability to influence at all levels of the organization.

Job DescriptionTitle: Brand Quality Control Coordinator Reports to: Manager or Director of Quality Department: Quality Assurance / Quality Control Responsibilities: • Facilitates the timely and accurate response to customer requests with regards to Quality / GMP documents, samples, and communications as it relates to quality responsibilities, including the release of RMs, Components, Bulk & FGs., • Ensure accuracy and completeness of all quality documents forwarded to the customer., • Review and facilitate the forwarding of samples for customer's approval., • Participate in customer conference calls as their Quality liaison., • Assist, as needed, R&D, Customer Service (CSRs), Process Engrg, etc., to expedite customer requests., • Maintain tracker of open quality issues as they pertain to the customer & issue biweekly updates to EWL management., • Update/Upload data to the customer's quality system, via their portal., • Coordinate customer-related activities with the CSR as required to support product disposition, • Support AQL inspection and investigations of customer's components or products, and issue reports., • Participate in customer line trials & assist in setting F&A instructions., • Minimum of Associate or Bachelor degree (Life Sciences, Engineering, related profession)., • Two+ years industry or related experience in cosmetic, device, food, or pharma., • Previous inspecting, auditing or manufacturing experience - a plus., • Data analysis, specification development skills., • Computer literate and effective communication skills. This is a full-time, hourly position with an approximate pay rate of $20–$22 per hour, including applicable overtime in accordance with federal and state regulations. Final compensation may vary based on factors such as knowledge, skills, and experience. The benefits package includes: • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR fuxc6zQADo

Job Description Job Summary: The EVP, Scientific Affairs oversees the operations of the Quality Assurance and Quality Control Departments for all divisions across multiple locations and has overall responsibility for the technical operations and the strategic planning of adequate resources needed to ensure the required quality of laboratory operations meet business requirements and customer deliverables. They will develop, implement, and periodically evaluate the QC/QA Department activities to ensure the organization’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization to meet the requirements of customers, consumers, and regulatory and accrediting agencies. The role is also responsible for ensuring cGMP compliance across all business divisions within the Company. The EVP, Scientific Affairs will be accountable for the timely release of products at all steps of the Manufacturing process, based on justifiable rationale, valid scientific data, process control items, etc. Principle Responsibilities: • Directs all Scientific Affairs and assumes responsibility for all Quality related matters; sets priorities and oversees the daily efforts of the QC/QA Team., • Provides guidance and works with various Departments in maintaining cGMP compliance within all business divisions of the Company., • Initiates Quality processes that drive continual improvement within the organization., • Conducts internal quality control audits and random inspections of each site’s Quality Management System as required and periodically reports on status of quality control and operations to executive leadership and, when required, regulatory agencies., • Provides support for third party cGMP certification audits and ensures appropriate corrective actions are conducted., • Directly involved with on-site regulatory (FDA, NJ-DHHS, etc.) inspections as well as internal and third-party audits and writing and overseeing responses to audits to comply with cGMP and GLP. Serves as the contact person and co-hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations., • Facilitates communication among production divisions and management. Provides support to Manufacturing and Product Development as required to troubleshoot production problems and collaborates with management and senior staff across production departments and roles to draft acceptable quality standards., • Evaluates internal and external laboratory capabilities. Recommends new testing procedures and equipment to support cGMP and customer specific requirements., • Develops and implement standards, methods, and procedures for inspection and testing, validation of systems and analytical processes, documentation, and change control systems that ensure the identity, purity, strength, and composition of ingredients and finished products are to specifications., • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements and monitor the compliance through robust internal audit program., • Ensures all laboratory controls and functions and all Quality Control functions as designated in 21 CFR GMP Part 110, 111 and 117 are in place, documented, monitored and enforced to maintain the QC Lab within a cGLP environment at all times., • Assess test results and approve recommended changes., • Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance., • Select, upkeep, calibrate, recertify, and document all instrumentation in the QC lab., • Oversee lot release of components, raw materials, and finished products., • Develop raw material specifications and finished product specifications once material has been through the Product Development process and route for signature., • Ensure sampling and testing priorities are consistent with Manufacturing, Production, and Customer Service schedules., • Preparation of analytical documentation (OOS, deviation reports, test methods, change controls, Certificate of Analysis) for incoming raw materials and finished goods., • Review technical control documentation (SOPs, Batch Records, test methods, specifications, COAs, etc.) from a Quality and Compliance perspective; ensure continuous improvement of departmental SOPs to stay up to date with regulatory and compliance guidelines; create, revise, and gain approval to implement lab SOPs and procedures and to review qualification documents for laboratory instrument/software as is necessary., • Maintain and improve department performance to meet requirements of Regulatory Authorities as well as the policies and standard procedures of the company., • Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories., • Provide technical guidance for validation of analytical methods and develop overall strategy to manage all critical reagents, reference standard, and reference control materials used in the laboratory., • Establish proper communication channels to manage, mentor direct reports to higher levels of management capability and provide strategic leadership to further strengthen the platform with a highly functional QC team., • Plan strategically/proactively with management of other platforms to ensure that resources are allocated adequately to meet each program’s needs., • Ensure that QC decisions are aligned with governance from Company Procedures and regulatory requirements., • Coordinate management structure of the laboratory to build Analytical datasets (release, and analytical verification) for Starting materials, In Process and Finished goods., • Identify gaps and assist with annual budget at both CAPEX and Operation levels. Direct – AVP, VP or Director of QC, QC/QA Team Indirect – Production Staff Supervisory Responsibilities: • Directs and oversees the quality control and quality assurance departments and supervisory staff., • Train QC/QA Team as necessary and validate their work periodically., • Perform annual performance reviews that are timely and productive and develop training plans with direct reports., • Handle discipline and termination of employees in accordance with company policy., • Ensure staff are provided with corporate communications. To perform this job successfully, an individual must be able to perform each principal responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education: BS degree in Chemistry, Engineering or Life Sciences required. Advanced degree preferred. Experience: 10 years in the manufacturing QC/QA field with a minimum of 5 years supervisory experience directing QC/QA and Documentation function within the Nutraceutical or Dietary Supplements industry is required. Solid overall knowledge of USP, FCC, and FDA guidelines as applied to testing of cosmetic and dietary supplement ingredients and finished goods. Experience leading FDA inspections is highly desirable. The desirable candidate will also be knowledgeable in analytical instrumentation (i.e., HPLC, GC, UV-Vis, FT-IR, Atomic Absorption, TLC and USP dissolution apparatus 1 and 2). Working knowledge of product stability studies and microbiological analysis of raw materials, in-process and finished goods required. Physical Requirements: Work requires ability to lift up to 25 pounds; sitting, standing, walking, bending and/or stooping for periods of five hours or more; moving and examining objects at high and low reach, and reading for periods of three hours or more; prolonged periods working on a computer. Position requires normal visual acuity. Additional Skills and Qualifications: Proven experience managing technical services and staff. Demonstrated knowledge of current cGMP requirements, regulations and standards to ensure the maintenance of the cGMP standard of quality. Thorough understanding of quality control standards and methodologies. Thorough understanding of manufacturing and production in the industry. Ability to read and interpret documents such as safety rules, operating and maintenance work instructions, procedure manuals and SDS sheets. Must have the ability to communicate effectively orally and in written form. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals. Must understand and use advanced statistical methods. Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Must have ability to solve complex problems involving multiple variables in standardized situations. Must have a deliberate and acute sense of documentation of all activities while in the manufacturing environment. Must be proficient with and be able to communicate via e-mail. Must be proficient with and able to use computer software including word processors & spreadsheets (Microsoft Word, Excel, Access), and ERP System. Proficient in oral and written communication skills. Must be able to communicate effectively in a cross functional team environment to complete work tasks as instructed. Must have sound judgment and decision-making skills. Excellent organizational skills and demonstrated attention to detail and thoroughness are critical. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Vital Health America is an Equal Opportunity Employer Company DescriptionVital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.Vital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.

Job Description We are seeking an experienced Senior QA Auditor with a strong background in Radiopharmaceuticals (RPT) to join our quality assurance team. This role plays a critical part in ensuring compliance with cGMP, GDP, FDA, EMA, and ICH regulatory standards while supporting the Pharmaceutical Quality System (PQS) through proactive auditing and continuous improvement initiatives. The ideal candidate is a detail-oriented professional with hands-on experience conducting internal and external audits across manufacturing, testing, and distribution operations. Key Responsibilities • Plan, conduct, and report on internal, external, and risk-based audits of RPT CMOs, suppliers, and internal processes., • Develop comprehensive audit plans, checklists, and schedules in alignment with regulatory and company standards., • Ensure strict adherence to FDA, EMA, ICH, and other relevant global compliance frameworks., • Review and approve deviations, CAPAs, and change controls, ensuring effective closure and documentation., • Issue detailed audit reports and maintain oversight of CAPA implementation and verification., • Guide operational teams on audit readiness and compliance requirements., • Support regulatory inspections and customer audits, ensuring seamless coordination and documentation., • Identify systemic quality issues and contribute to the development of process improvement initiatives., • Bachelor's degree in Life Sciences, Pharmacy, or a related discipline., • 35 years of experience in Radiopharmaceuticals, with a minimum of 2 years in auditing., • In-depth knowledge of RPT cGMP, GDP, and global regulatory requirements., • Proven ability to plan, execute, and report audits independently., • Strong analytical, organizational, and report-writing skills., • Excellent communication skills and attention to detail., • ASQ Certified Quality Auditor (CQA)., • ISO 9001 Lead Auditor Certification. cGMP | GDP | FDA | EMA | ICH | RPT cGMP Regulatory Inspections | Customer Audits | CAPA | Deviations | Change Controls Audit Planning | Checklists | Scheduling | Reporting | Process Improvements Compliance Requirements | Audit Readiness | Report Writing | PQS | ISO 9001 Excellent Analytical & Communication Skills

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

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 DescriptionJob Title: Sr. Auditor Work Location: Paramus, NJ Work Type: Onsite Work Authorization: Only GC / US Citizens About the Role: The RPT QA Auditor is responsible for planning, conducting, and reporting internal and external audits to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. This role plays a key part in strengthening the Pharmaceutical Quality System (PQS) by identifying compliance gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution activities. Key Responsibilities: • Plan, schedule, and conduct routine, for-cause, and risk-based audits of internal departments, contract manufacturers (CMOs), and suppliers., • Develop detailed audit plans, checklists, and audit schedules based on risk assessment and regulatory focus areas., • Ensure compliance with FDA, EMA, ICH, and other applicable global regulatory guidelines., • Review and approve deviations, CAPAs, and change controls to ensure timely and effective resolution., • Document audit observations, issue formal audit reports, and communicate findings to stakeholders., • Track and verify implementation and effectiveness of corrective and preventive actions (CAPAs)., • Provide guidance and training to internal teams on audit readiness and compliance requirements., • Support regulatory inspections and customer audits as required., • Identify systemic quality issues and recommend process improvements across the PQS., • Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific field., • 3–5 years of experience in Radio Pharmaceuticals, including at least 2 years in auditing or QA compliance., • Strong knowledge of RPT cGMP, GDP, and relevant global regulatory requirements., • Excellent attention to detail, analytical thinking, and problem-solving skills., • Strong written and verbal communication skills, with the ability to prepare clear audit reports., • ASQ Certified Quality Auditor (CQA) certification., • ISO 9001 Lead Auditor certification., • Opportunity to work in a highly regulated and growing sector of Radio Pharmaceuticals., • Collaborate with a mission-driven team focused on patient safety, compliance, and quality excellence., • Gain exposure to global quality systems and diverse manufacturing and supplier environments.

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 Description Job Overview We are seeking a dedicated and detail-oriented Warehouse Quality Control Supervisor to join our team. A Quality Supervisor in a warehouse is responsible for overseeing product quality, compliance with standards, and ensuring warehouse processes meet customer and regulatory requirements. The role bridges operations, inventory, and quality assurance. Heres a breakdown: Key Responsibilities • Quality Control & Assurance, • Inspect inbound and outbound shipments for accuracy, damage, and compliance with company/customer standards., • Enforce proper handling, labeling, and packaging practices., • Lead audits (internal and external)., • Team Supervision, • Train and oversee QC (quality control) staff or warehouse associates performing inspections., • Assign daily tasks, monitor performance, and provide coaching., • Ensure safety and compliance protocols are followed., • Process & Compliance, • Maintain SOPs (Standard Operating Procedures) for warehouse quality practices., • Ensure compliance with ISO, FDA, GMP, or customer-specific standards, • Investigate non-conformances, document issues, and recommend corrective actions., • Reporting & Metrics, • Track KPIs such as defect rates, audit scores, and returns., • Prepare reports for warehouse/operations management., • Experience in warehouse, distribution, or manufacturing quality control., • Knowledge of WMS systems and inventory processes., • Strong attention to detail and organizational skills., • Leadership and training abilities., • High school diploma; bachelors degree often preferred (supply chain, logistics, QA, or related)., • 25+ years in warehouse/QA environment., • Supervisory or lead experience. Qualifications: High school diploma or GED Warehouse Supervisor Exprience Quality control • Logistics Preferred: Operations management • Organizational skills, • Warehouse management system, • Supply chain management, • Product quality assurance, • Quality control process implementation

Job Description We are conducting a search for an experienced Director of Quality Control / Quality Assurance to lead and manage our quality programs in a fast-paced, high-volume food manufacturing environment. The ideal candidate is a certified SQF Practitioner with a proven track record of successful third-party, regulatory, and customer audits, and extensive experience in both foodservice and retail segments. This leadership role is critical to ensuring our products consistently meet the highest standards of safety, quality, and compliance. What You'll Do: • Direct and oversee all QC/QA activities across food manufacturing operations., • Maintain and improve the company’s SQF program; act as the designated SQF Practitioner., • Lead all audit activities (SQF, FDA, , customer, and third-party), ensuring successful outcomes and timely resolution of non-conformities., • Implement and monitor HACCP plans, food safety systems, GMPs, SOPs, and other quality-related programs., • Supervise and develop the QA/QC team; drive a culture of accountability and continuous improvement., • Partner with cross-functional teams including Operations, R&D, and Supply Chain to optimize product quality and efficiency., • Ensure thorough documentation, traceability, and compliance across all quality-related functions., • Manage and respond to customer complaints, deviations, and corrective/preventive actions (CAPAs)., • Monitor industry trends and regulatory updates to ensure ongoing compliance. What You'll Bring: • Bachelor’s degree in Food Science, Microbiology, or related field., • Certified SQF Practitioner (REQUIRED)., • Minimum 10 years of QA/QC experience in the food manufacturing industry, with leadership responsibilities., • Demonstrated success managing quality in both foodservice and retail channels., • Proven track record of passing regulatory, third-party, and customer audits., • Deep understanding of HACCP, GMPs, FSMA, FDA regulations., • Strong organizational, communication, and leadership skills., • Ability to thrive in a high-speed, hands-on manufacturing environment., • Experience with refrigerated, shelf-stable, or specialty food products is a plus., • Bilingual (English and Spanish) is a plus

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 Job Duties: Performs and interprets automated and manual testing procedures on blood, urine and fluid specimens in the laboratory. Evaluates specimen/test orders for acceptance/rejection according to guidelines; accessions specimens accurately. Meets established TAT and productivity standards. Recognizes and resolves errors/discrepancies or problems and notifies appropriate personnel. Is proficient with all IT systems; can order, cancel, retrieve result, review work lists, sample collections, and test status. Addresses critical results and delivers STAT results properly according to policy. Correlates results with diagnosis and compares previous results if necessary. Can operate all Laboratory testing instruments; can recognize, troubleshoot and resolve instrument issues. Ensures proper function, maintenance and QC of each instrument; ensures compliance with QC, maintenance, temperature and reagent records. Performs proficiency testing and quality audits as needed. Ensures compliance with JCAHO, FDA, CAP, AABB and NJDOH. Maintain the record of reagents and supply; reports reagents shortage to the supervisor or designee; ensures that all reagents used for testing are in date and show no signs of drift or contamination as indicated in the daily QC data. Assists with training new employees, participates in teaching students. Demonstrates knowledge and follows to all department safety procedures and policies. Ensures proper handling of chemical and bio-hazard materials. Works weekdays, weekends and holidays as scheduled. Conducts personal business on non-productive time, limits socializing to ensure the work flow continues uninterrupted. Shows leadership quality; assumes responsibility in absence of supervisor. Attends department meetings and participates in continue education. EDUCATION + EXPERIENCE REQUIREMENTS: BS degree from an accredited institution with a major in medical technology. Minimum of 1 year clinical laboratory experience, which may be concurrent or subsequent to education, required. MT (ASCP) or equivalent certification desired. May be required to meet specific state requirements. CREDENTIALS + QUALIFICATIONS: Degrees from foreign institutions will require credential equivalency evaluation. Ability to provide excellent customer service internally and externally. Possess superior written and verbal communication skills. Ability to read, understand and follow detailed procedures. Analytical, numerical and reasoning abilities necessary. Proven skills of critical thinking, problem solving, and decision making. Ability to prioritize, organize, and handle a high volume workload efficiently essential. Good close vision and color perception required.

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 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 Description About the Job The primary function of this position is to oversee a full portfolio of approved and unapproved ANDA products. The incumbent might also be designated as U.S. Agent (back-up) for the U.S. Office for both ANDAs (GPI USA) and API (GLS India). The position includes a number of responsibilities that will require excellent communication to support both internal and external customers (globally) including the U.S. FDA. Job Responsibilities Note: These statements are not intended to be an exhaustive list of all responsibilities and duties. • Manage at least one (1) and possibly up to (2) direct reports to ensure their assigned responsibilities are completed accurately and on a timely basis to support the needs of the business for internal/external customers., • Support the U.S. Office for more than 170 approved ANDAs and all unapproved (under review ANDAs) as U.S. Agent back-up for all Glenmark subsidiaries including GPL, GSSA, GPI and GLS. The successful candidate will need to be able to review and sign various submissions to FDA. It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work. Form 2252 for Annual Reports., • Provide support/RA strategy needed to achieve timely approvals with the Agency., • Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and Corresponding Acknowledgements, ANDA Amendments and Responses to CRL (minor/major), DRLs and IRs. The US Office is responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved products, RA India including post-approval team for post-approval activities. The email list is provided for such communications which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management, Demand Planning, Marketing and others identified on the list. It’s very important that these communications be shared with the FDA on a timely basis (typically the same day received from the FDA). Separate communications received from the FDA to support GLS will be sent to the GLS leadership team as identified., • Support OTC submissions, as needed, for ANDA conversion to OTC or OTC Monograph direct including any labeling reviews and updates., • Ensure all manufacturing, packaging, labeling, testing and BA/BE sites are registered with FDA in the CDER Portal, as applicable, • Ensure the payments are made on the scheduled due date to support all manufacturing sites., • Submit all Recalls and FARS to FDA for ANDAs and OTCs, as needed to support commercial. Submit subsequent updates to Recalls / FARS to FDA on a timely basis to meet the required deadline., • Submit controlled correspondences for R&D through CDER NextGen Portal., • Submission of PLAIRS accurately and timely as provided to the US Office., • Shipping samples to the FDA for CDRH evaluation of devices., • Submit pre-ANDA Meeting Packages to FDA, as needed, • Submit Responses to FDA Observations to support manufacturing sites, as needed Qualifications Education • Extensive experience in the pharmaceutical industry with at least 10+ years’ experience in a regulatory affairs., • Primary experience must be managing a significant number of generic drug products (ANDAs & OTCs)., • Capable and has the desire to manage at direct reports, as assigned., • Excellent communication skills including: verbal, reading and writing., • Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports trained according to support labeling., • Proficient using MS word, MS excel, reviewing Drugs@FDA databases, USP database, FDA Orange Book, DP Specifie Bioequivalence Guideline and Dailymed Labeling, • The successful candidate must be proactive in reading and understanding assigned materials including FDA guidance, 21 CFR, USP general chapters, USP specific monographs, and internal SOPs as assigned., • The candidate must be a highly motivated, willing to be trained and be a self-learner in order to execute assigned tasks with attention to the details., • This will require direct prior experience doing the described activities., • It will in some instances require training, reading internal Standard Operating Procedures (SOPs), in-person training, and training by viewing FDA SBIA learning on-line video seminars or reading FDA guidance., • Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly., • Communicate with Supervisor and other Sr. Management on a timely basis when potential issues/concerns arise., • Use critical thinking skills and attention to detail is essential., • Ask questions and/or advice when in doubt., • The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties., • The noise level in the work environment is typical of that of an office, • Incumbent may encounter frequent interruptions throughout the workday. Salary Range - $160,000 – 185,000 The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. Benefits include: • Paid time off, • 401k plus company match, • Company paid health benefits, • Dental, • Vision, • Onsite access to company gym, • Paid Employee Referral Program, • EAP – Employee Assistance Program, • Accident Insurance, • Critical Illness Insurance, • Short-Term Disability, • Life and AD & D Insurance, • Whole Life Insurance, • Pet Insurance and so much more! About the Company Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live. This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice. Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job DescriptionJob Title: GCP Sr. Auditor Work Location: Paramus, NJ Contract Type: W2 Only Work Type: Hybrid (3 days/week at Office) Travel Required: Upto ~10% site travel Work Authorization: Only GC / US Citizens About the Role: As the GCP Quality Assurance Senior Auditor, you will play a critical role in ensuring compliance with global GxP regulations, managing audits across clinical, nonclinical, and pharmacovigilance (PV) domains, and supporting high-integrity quality systems. You will report to the Director of GCP/PV Quality Assurance and will partner closely with clinical operations, vendor management, and cross-functional QA teams. Key Responsibilities: • Plan and lead internal and external GxP audits (clinical trials, vendor/CRO audits, investigator sites, CMOs, etc.), • Conduct risk-based audits of clinical processes and vendor systems (e.g. IRT, EDC), • Prepare detailed audit reports, issue non-conformances, and follow through on corrective / preventive actions (CAPAs), • Interface with stakeholders (vendors, partners, CROs, CMOs, investigators) to ensure audit findings are resolved effectively, • Support preparation for regulatory inspections and site audits, • Assist in quality improvement initiatives and continual enhancement of QA processes and practices, • Review and interpret clinical development and safety policies, SOPs, guidelines (e.g. ICH E6, GCP, applicable FDA/EMA regulations), • Provide QA support to cross-functional teams involved in clinical operations, nonclinical, and safety/PV, • Maintain audit schedules, metrics, and quality documentation, • Bachelor’s degree in science, healthcare, life sciences, or related discipline, • Minimum 5+ years in pharmaceutical or biotech industry, • Strong experience in GCP audits (internal/external) and clinical quality assurance, • Familiarity auditing CROs, CMOs, investigator sites, and clinical vendors, • Knowledge of quality systems (QMS), SOPs, compliance documentation, CAPA processes, • Ability to audit clinical systems such as IRT, EDC, and other vendor systems, • Solid understanding of global regulatory guidelines (FDA, EMA, ICH GCP), • Strong report writing, communication, and stakeholder management skills, • Previous experience in neurology, psychiatry, or CNS therapeutic area, • Experience in pharmacovigilance / safety audits, • Office environment, with occasional site or vendor visits, • Ability to travel as needed (≈10%), • Must be comfortable working with and reviewing clinical and audit documentation, • On-site presence required for key audit and inspection events

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 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 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. Japan. Job Summary: Responsible for the management and execution of various aspects of translational and early-stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid position that requires to be in the Paramus office twice a week. Essential Duties and Responsibilities: • Develop and deliver program level translational and early-stage clinical drug development strategy, • Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and that achieve biomarker-driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs, • Integrate with colleagues in discovery research and research-stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof-of-mechanism, pharmacodynamic activity, PK/PD relationships., • Plan, implement, manage and report for regional or global clinical studies., • Manage and Lead selection process of CROs for regional or global clinical studies., • Direct, oversight and manage the performance of study vendors (e.g. CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors., • Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets., • Good cross-functional team leader who fosters team spirit and team motivation (teamwork), • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans, • Decision-making and problem-solving skills, • Ability to handle multiple tasks and prioritize, • Strong organizational, communication and presentation skills, • PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered., • Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Ph2/3 or registrational programs desired., • Excellent understanding of drug development, regulatory processes and clinical development 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 $175,000 to $220, 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 NS Pharma is an EEO employer.

Job DescriptionJob Title: Project Manager, Clinical Trials Job Description The Project Manager for Clinical Trials will manage multiple investigator-initiated clinical trials, overseeing reports and assisting with statistical analysis. You will be responsible for assisting the study team in preparing for audits by various governing agencies, study monitors, and other compliance efforts. The role includes overseeing and driving projects from concept to completion, resulting in publications, clinical study reports, and final reports to funding agencies. Additionally, you will act as a liaison between investigators, funding agencies, and third-party contractors, ensuring smooth communication and resolution of study-specific issues. Responsibilities • Collaborate with research team members including Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, Contract Research Organizations, and medical center employees., • Coordinate and assist in developing protocols, informed consent forms, monitoring, and validation plans., • Oversee the submission of IND Applications to the FDA as needed., • Design case report forms and work with data analysts for database development., • Coordinate study manuals of procedures for site coordinators, pharmacists, and laboratory technicians., • Develop and present training materials for investigators, coordinators, pharmacists, laboratory technicians, and monitors., • Ensure trials progress according to quality standards and federal regulations., • Guide on-site monitors by providing training, identifying issues, assisting with issue resolution, and tracking corrective action plans., • Arrange, prepare for, and document meetings between clinical researchers, sponsors, and coordinating center members., • Build research infrastructure to support multi-center clinical trials., • Perform project management for ad hoc projects as needed., • Adhere to the standards identified in the Medical Center's Organizational Competencies.Essential Skills, • 8+ years of clinical research experience., • Experience in clinical protocol and trial document development., • Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.Additional Skills & Qualifications, • Bachelor's degree in a scientific or medical discipline., • Experience with informed consent forms, investigational device exemption, serious adverse event reporting, IND safety reports, and IRB processes.Work Environment The work environment is within a leading healthcare system that is part of the National Cancer Institute-designated comprehensive cancer center. You will be part of a team that evaluates novel cancer treatments and technologies, providing patients with increased access to clinical trials. The healthcare system offers a complete spectrum of services, allowing you to apply your skills in various settings while advancing your career. Recognized as a top cancer center, the organization provides innovative cancer care, with a focus on patient-centered treatment plans. Job Type & Location This is a Permanent position based out of Hackensack, New Jersey. Pay and Benefits The pay range for this position is $100000.00 - $126000.00/yr. HMH Perm benefits offered Workplace Type This is a hybrid position in Hackensack,NJ. Application Deadline This position is anticipated to close on Oct 30, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No JOB DESCRIPTION: The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES: Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS: 5+ years of pharmaceutical experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job Description Experience Required: 5 Years Education Level: Bachelor's Degree Job Function: Accounting/Auditing Industry: Pharmaceuticals Relocation Assistance: No Visa Sponsorship Eligibility: No Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with current Good Manufacturing Practice (cGMP), regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules to ensure comprehensive audits., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Guide compliance requirements and audit readiness., • Support regulatory inspections and customer audits., • Identify systemic issues and recommend process improvements to enhance efficiency and effectiveness., • Stay updated on evolving regulatory requirements and industry best practices. Qualifications: • Bachelor's degree in Life Sciences, Pharmacy, or related field., • 3–5 years in Radio Pharmaceuticals, with at least 2 years in auditing, • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)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? • 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 #PROFESSIONAL

Job Description About Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced IRB Coordinator Consultant to join the Vitalief team as a contractor. In this role, you will support a leading hospital research center in Livingston, NJ, administering and overseeing Institutional Review Board (IRB) activities to ensure compliance with federal, state, and institutional regulations governing human subjects research. This role supports investigators, staff, and IRB members in the preparation, review, and approval of research protocols, while also assisting with Nussbaum grant activities. Engagement Details • Work Hours: 40 hours per week (8am to 4pm M-F), • Work Location: 100% on-site in Livingston, NJ., • Contract Duration: 6 months (possible extension), • Pay Rate: Market competitive (depends on experience level) Responsibilities:, • Under the direction of the Director of Graduate Medical Education and Clinical Research, coordinate and manage all IRB activities, meetings, and communications., • Review protocol submissions for completeness and accuracy; recommend appropriate level of review., • Draft and issue correspondence reflecting IRB deliberations and decisions., • Provide regulatory and methodological guidance to investigators, staff, students, and IRB members., • Maintain compliance with OHRP, FDA, ICH/GCP, and institutional regulations., • Manage IRB databases, tracking systems, and protocol documentation., • Assist with emergency use protocols and special meetings as needed., • Schedule and support Institutional Research Committee meetings, prepare agendas/minutes, and follow up on action items., • Collaborate with other system IRB Coordinators and departmental staff., • Bachelor’s degree in a scientific or health-related field required; Master’s degree preferred., • Three (3) years of experience in clinical research and research administration, including two (2) years of IRB operations experience., • Strong understanding of IRB regulations, ethical research standards, and ICH/GCP guidelines., • Excellent written and verbal communication skills., • Ability to demonstrate professionalism, clear communication, and respect in all interactions., • Passionate in supporting teamwork and collaborative problem-solving., • Apply continuous quality improvement principles to research operations., • Work independently with accountability, sound judgment, and openness to feedback., • Strong organizational and time management abilities; must be self-motivated and able to multi-task on a variety of projects., • Detail-oriented with strong organizational and follow-up skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint); database management experience preferred., • Certified IRB Professional (CIP®) is a plus., • Knowledge of medical terminology preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR lfKp3BPFdR

Job Description Job Title: Formulation Scientist Job Description The Formulation Scientist will be responsible for researching, generating, and directing new product formulations from conceptualization through development and manufacture. The role involves collaboration with sales, operations, and quality assurance teams to generate innovative formulations, troubleshoot technical issues, and ensure proper documentation for new product development. The position also requires the development of recipes and prototypes to drive new concepts forward. Responsibilities • Research, generate, and direct new product formulations from concept through to manufacture., • Collaborate with sales to create new formulations for customers and assist in new product development., • Work with operations teams to troubleshoot technical, formulation, and processing issues., • Collaborate with the Quality Assurance department to develop documentation for new projects., • Utilize knowledge of production equipment like tablet presses and capsule filling machines to solve product performance issues., • Troubleshoot and solve issues with tablet and capsule manufacturing processes., • Initiate Label Copy for supplement facts and regulatory requirements., • Drive and manage all aspects of product development, integrating consumer insights., • Collaborate with sales and marketing to develop product quote processes., • Source and identify new concepts, ingredients, and product forms., • Maintain competitive knowledge regarding new technologies, ingredients, and product forms., • Prepare materials and present new launches at sales meetings., • Participate in product and package configuration activities., • Ensure adherence to company SOPs and quality control protocols., • Effectively communicate technical information to non-technical audiences., • Participate in public relations, media interviews, trade shows, and similar events with prior management approval., • Prioritize and manage multiple customer products., • Proven experience in formulation, chemistry, and laboratory practices., • Strong understanding of GMP, quality control, and FDA regulations., • Ability to develop vitamin and supplement products and research ingredients., • Experience in improving product flavor and quality consistency., • Proficiency in integrating from bench to batch production., • Experience in directing production adjustments to formulation and machinery., • Bachelor’s degree in Chemistry, Engineering, Food Science, Nutrition/Dietetics, or related field., • Minimum of 3 years of hands-on experience as a Formulator in a manufacturing environment, preferably in dietary supplements or food & beverage industry., • Strong working knowledge of basic lab techniques and cGMP standards., • Ability to read and interpret safety rules, operating and maintenance instructions, and SDS sheets., • Strong knowledge of ingredient costing and technology., • Ability to perform arithmetic operations using whole numbers, fractions, and decimals., • Understanding of simple statistical methods., • Ability to solve moderately complex problems with multiple variables., • Acute sense of documentation within the manufacturing environment., • Proficiency in Microsoft Word and Excel., • Strong presentation skills to communicate new product ideas persuasively., • The work environment requires the ability to lift up to 50 pounds unassisted, or up to 100 pounds with mechanical assistance., • The role involves standing, walking, bending, and stooping for long periods, as well as moving and examining objects at various heights., • The position demands normal visual acuity and involves reading for extended periods., • A high level of organization and the ability to prioritize effectively are essential, along with demonstrated attention to detail and thoroughness. The pay range for this position is $60.00 - $85.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Fairfield,NJ. Application Deadline This position is anticipated to close on Nov 7, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Director, Business Development - Clinical Research Director, Clinical Business Development Full Time Remote-USA Based Reports to: Senior Vice President, Clinical Services Frontage Laboratories Inc. Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, clinical research, and core laboratory services for clinical trials. Frontage Clinical Services At Frontage, we leverage more than 25 years of experience to develop a unique approach to overcome the challenges of every clinical study, while maximizing efficiency and mitigating risk. We apply best practices in study design and execution to advance each study to completion. Responsibilities: • Secure and retain business through professional, consultative, and proactive sales activities directed at key decision makers, • Strong negotiating skills, knowledge of legal contracts and experience with RFIs/RFPs and competitive bidding processes, • Analyze potential opportunities and develop sales plans for each target account, develop in-depth knowledge of the customer organization, • Ensure appropriate strategy/solution is proposed to clients, • Monitor actions and results against plans, • Lead client visits to the Frontage facilities, • Coordinate with scientific and operations staff to prepare and lead the sales presentations, present comprehensive proposals, and lead follow-up activities, • Monitor sponsor satisfaction by regular communication with the clients/sponsors, • Record all client/sponsor sales related (opportunities, CDA, MSA, Site Visits, Face to Face Meetings, etc.) activities in CRM (salesforce) system, • BS degree or above, life science preferred., • 3+ years’ experience in a clinical operation role and /or 1+ years’ experience selling early-stage clinical research services., • Solid understanding of the principles of drug discovery and development., • Knowledge and experience in DMPK & Safety Toxicology, • Knowledge and understanding of FDA, GCP, and ICH regulations and guidance, • Highly proficient in using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel., • Attention to detail and ability to work simultaneously on multiple priorities. Able to adapt and be flexible to changing priorities., • Excellent oral and written communication skills., • Ability to travel.

Job Description We are Licensed Customs House Brokers looking for a highly motivated, customer service oriented data entry clerk. The hours are from 8:30 to 5:00. Import Entry Specialist - TCRS4556 HIGH LEVEL OVERVIEW The Import Entry Specialist is responsible for the timely and accurate filing of customs entries ensuring compliance with CBP and other government regulations. This is an on-site position based in Englewood Cliffs, NJ. EXPECTATIONS • Prepare, review, & process import entry documentation for air/ocean shipments and border crossings, • Work with CBP and other government agencies to resolve any compliance issues, holds, or queries, • Work with internal and external partners to provide timely clearance updates, • Maintain and manage client product database with HTS classification, • Stay current with changes to regulations and understand the impact to import entry processes, • Knowledge of U.S. Customs regulations; HTS Classification, COO, Valuation, • 3 years’ Customs Brokerage experience preferred, • Strong attention to detail, accuracy in data entry, and time-management skills, • Organizational skills and the ability to multitask in a fast-paced environment, • Understanding of FDA, DOT, and LACEY import regulations, • Knowledge of trade automation tools; CargoWise, ACE, etc., • Experience with import entry software, ideally Decartes/NetCHB, • Experience in Microsoft applications- Excel, Word, PowerPoint, OutlookCompany DescriptionLicensed Customs House BrokerLicensed Customs House Broker

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

Job DescriptionSenior Business Development RepresentativeJoin a Mission-Critical Team Where Precision Meets GrowthAt SQA Services, you won’t just generate leads, you’ll architect pathways into some of the most sophisticated and regulated markets on the planet. Our clients in aerospace, life sciences, and medical devices operate where failure isn't an option, compliance is paramount, and every decision carries profound consequences. As our Senior Business Development Representative, you won't be making cold calls to small businesses. Instead, you'll be the strategic entry point for enterprise deals that can transform both our clients' operations and our company's trajectory. The Role: Strategic Market Intelligence & Opportunity ArchitectureYou'll partner directly with our most experienced enterprise sellers to penetrate accounts where buying cycles span months, stakeholder groups include C-suite executives, and regulatory considerations influence every conversation. This isn't traditional prospecting; it's strategic market development in environments where your understanding of compliance frameworks, quality management systems, and risk mitigation becomes as important as your sales skills. Your Strategic Impact:Account Intelligence Development: Research and map complex organizational structures within Fortune 500 aerospace manufacturers, pharmaceutical companies, and medical device innovatorsRegulatory-Aware Messaging: Craft sophisticated outreach that demonstrates a deep understanding of FDA regulations, AS9100 standards, and ISO 13485 requirementsExecutive-Level Engagement: Connect with VP-level and C-suite decision makers who oversee quality, compliance, and operational excellence initiativesPartnership-Driven Prospecting: Collaborate with senior Account Executives to develop multi-threaded account penetration strategiesEnterprise Meeting Generation: Secure high-value discovery meetings that often lead to six and seven-figure opportunities Your Daily Excellence • Execute sophisticated, multi-touch campaigns targeting key stakeholders within our 200+ enterprise target accounts, • Utilize advanced SPICED qualification frameworks, understanding regulatory pressures, audit cycles, and compliance modernization initiatives, • Coordinate with senior sellers to align outbound efforts with broader account strategies, • Generate 6+ qualified enterprise meetings monthly that advance strategic opportunities, • Stay current on regulatory changes, industry trends, and compliance challenges affecting aerospace, life sciences, and medical device sectors, • Develop industry-specific messaging that resonates with quality directors, compliance officers, and operational leaders, • Participate in industry conferences and webinars to deepen sector expertise, • Leverage HubSpot to maintain detailed account intelligence and opportunity progression, • Create comprehensive account profiles, including regulatory status, recent audits, and strategic initiatives, • Track sophisticated metrics, including engagement quality, stakeholder mapping progress, and regulatory event correlationWhat Sets You Apart, • Proven BDR Excellence: 3+ years of demonstrated success in business development, preferably in enterprise or regulated environments, • Sophisticated Communication: Ability to engage confidently with senior executives and articulate complex regulatory and technical concepts, • Strategic Mindset: Understanding that enterprise sales requires patience, persistence, and strategic thinking beyond typical transactional approaches, • Regulatory Curiosity: Genuine interest in learning about compliance frameworks and how they impact business operations, • Experience in regulated industries (aerospace, pharmaceuticals, medical devices, electronics, or similar), • Enterprise sales environment exposure, where deals involve multiple stakeholders and extended cycles, • Understanding of quality management systems, compliance frameworks, or regulatory requirements, • Track record of exceeding targets in sophisticated sales environmentsWhy This Opportunity Transforms Your Career, • Work alongside seasoned enterprise sellers who mentor and develop your strategic selling capabilities, • Gain deep expertise in regulated industries that will position you to transition into an Account Executive role at SQA, • Participate in high-stakes deals where your contributions directly impact company growth, • Clear path to Account Executive role within 18-24 months for top performers, • Exposure to C-suite executives and complex enterprise decision-making processes, • Build expertise in markets where specialized knowledge commands premium compensationKey Performance Indicators, • Enterprise Meetings Generated: 6+ qualified monthly meetings with senior stakeholders, • Account Penetration: Multi-stakeholder engagement within target enterprise accounts, • Meeting-to-Opportunity Conversion: 70%+ of generated meetings advance to formal opportunities, • Strategic Outreach Volume: 5-10 targeted touches daily across multiple channels, • Account Research Depth: Comprehensive stakeholder mapping for all target accounts, • Regulatory Awareness: Demonstrated understanding of industry-specific compliance requirements

Job Description Job Summary: The RPT QA Auditor is responsible for planning, conducting, and reporting on internal and external audits to ensure compliance with cGMP, regulatory requirements, and company quality standards. This role supports the Pharmaceutical Quality System (PQS) by identifying gaps, recommending corrective actions, and driving continuous improvement across manufacturing, testing, and distribution processes. Key Responsibilities: • Conduct routine, for-cause, and risk-based audits of internal processes, RPT CMOs, and suppliers., • Prepare detailed audit plans, checklists, and schedules., • Ensure adherence to FDA, EMA, ICH, and other applicable regulatory guidelines., • Review and approve deviations, CAPAs, and change controls., • Document audit observations and issue formal audit reports., • Track and verify implementation of corrective and preventive actions (CAPAs)., • Provide guidance on compliance requirements and audit readiness., • Support regulatory inspections and customer audits., • Identify systemic issues and recommend process improvements., • Stay updated on evolving regulatory requirements and industry best practices. Qualifications: • Bachelors degree in Life Sciences, Pharmacy, or related field., • 35 years in Radio Pharmaceuticals, with at least 2 years in auditing., • Strong knowledge of RPT cGMP, GDP, and global regulatory requirements., • Excellent attention to detail and analytical skills., • Strong communication and report-writing abilities., • Ability to travel (up to 10%) for audits. Preferred Certifications: • ASQ Certified Quality Auditor (CQA), • ISO 9001 Lead Auditor, • GCP/GMP auditing certifications

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.

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 Description PER DIEM OPPORTUNITIES AVAILABLE Onsite Women's Health is on a mission to improve women's healthcare. In partnership with forward-thinking providers across the country, Onsite Women's Health offers comprehensive mammography services with clinical expertise, innovative technology, and proprietary protocols that delivers personalized, convenient breast care for the patient. Convenience drives compliance, and compliance saves lives.Convenience is critical to ensure that most women have time to remain compliant with their breast care. By offering mammography and breast care within the patient's primary care or OB/GYN practice and scheduling appointments in coordination with an annual exam, compliance is easier to accomplish. The Opportunity The OWH program is unparalleled, making breast cancer screening more convenient for women. Do you want a flexible work schedule? Can you be available to cover on a moment's notice? Do you want to experience different office environments? Then come to Onsite Women's Health as a Per Diem Technologist! See yourself here. At Onsite we don't work weekends or after hours and offer the opportunity to use the latest 3D tomosynthesis digital mammography equipment in an OB/Gyn office environment. If you are an experienced mammographer, someone who can work independently and wants to have an impact on each and every patient, join us as a Per Diem. What do you need to be the right candidate for this role? • Must be up to date on all CME credits., • Must be very patient centric, compassionate, and computer savvy., • Able to perform a variety of technical activities associated with the performance of screening and diagnostic mammography procedures., • Flexible with the ability to multi-task., • Specializes in the production of screening and diagnostic mammograms for the detection of breast cancers and lesions., • Responsible for the initial and ongoing success of the mammography service in the practice in which one works. Assist practice in any and all ways possible to be sure all eligible age-appropriate patients have annual screening mammograms., • Prepares patients for the mammographic procedure., • Explains procedures to the patient to reduce anxieties and obtain patient cooperation., • Moves mammographic equipment to specific positions and adjusts controls to set exposure factors based on knowledge of radiographic exposure techniques and protocols., • Practices radiation protection techniques by using beam restrictive devices, patient shielding skills., • Follows prescribed safety standards in operating all required equipment., • Examines digital images for image quality., • Ensures equipment is in proper working order at all times., • Performs all required QA testing required to comply with MQSA, ACR and State requirements/regulations., • Maintains patient confidentiality at all times., • Processes routine paperwork and all required data entry., • Participates in professional development activities and maintains professional affiliations., • Prepares all required reports and data pursuant to MQSA and State requirements., • Assists the Radiologist with QA/QC reporting., • Performs all mammography tracking following MQSA guidelines and requirements., • Maintains all QA documents necessary to exceed Annual FDA Inspection requirements. Experience:

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 Description EHS Specialist POSITION OBJECTIVE This position will implement and maintain FPC USA’s EHS (Environment, Health and Safety) management system to ensure all aspects of the EHS programs are in compliance with local, state, and federal regulations, adhering to corporate EHS policies, procedures, industrial standards and ISO requirements (e.g. ISO 14001, 45001, 14040 and 1467). Additional responsibilities include EHS compliance audit, training scheduling, corrective action tracking, and other EHS related activities (e.g. Product safety, DOT/SDS and Product LCA assessment). MAJOR AREAS OF ACCOUNTABILITY • Implements and maintains FPC USA’s EHS management system to ensure compliance with local, state, and federal regulations, industrial, ISO standards and corporate policies., • Acts as a liaison to work with plant site EHS personnel to ensure sites’ and corporate EHS programs are aligning with each other and meet local, state, federal regulatory requirements and applicable industrial standards., • Coordinates with plant sites for EHS management system implementation and regulatory compliance audit, scheduling, and corrective action tracking., • Acts as Corporate EHS Master Training Plan PIC (person-in-charge) for developing, maintaining, scheduling and tracking progress of training for EHS related programs, • Utilizes knowledge management system (KMS) “Auditor” to maintain audit protocols, track audit findings, corrective actions and to verify completion for continue improvement., • Assists with stakeholders to monitor new and amended Federal EHS regulations and industrial standards and prepare regulatory memo for Management as necessary to ensure compliance., • Assists in maintaining corporate procedures (e.g. Product Stewardship manual), policies and guidance documents in conform to the company’s document retention procedures. (i.e. Intranet), • Works with Product Stewardship team to develop and maintain FPC regulatory database including ImageWave SDS database. QUALIFICATIONS • 5 years of work experience in chemical, engineering, safety, environment, or related scientific discipline., • Training and/or auditing experience in EHS management systems and/or ISO standards, • General knowledge of petrochemical and plastics production beneficial, • Experience in working and communicating with different staff departments (e.g. Sales, production, technical, et al.), • Strong knowledge of chemical, environmental, EHS and other scientific principles., • Knowledge of the structure of U.S. regulations (e.g. EPA, OSHA, and FDA) and ISO standards.Company DescriptionFounded in 1978, Formosa Plastics Corporation, U.S.A. (Formosa Plastics) is a growing, vertically-integrated supplier of plastic resins and petrochemicals. With annual revenues of more than $5 billion, we employ over 2,800 people who operate 20 production units in six business divisions - Olefins, Polyolefins, Vinyl, Specialty Polyvinyl Chloride, Chlor-Alkali, and Oil & Gas. Formosa Plastics offers a full line of polyvinyl chloride, polyethylene and polypropylene resins, caustic soda and other petrochemicals that deliver the consistency, performance and quality that customers demand. We market our polypropylene and polyethylene resins under the Formolene® tradename; we market our suspension PVC and specialty (dispersion) PVC resins under the Formolon® tradename. We also produce and sell caustic soda, ethylene dichloride, commercial bleach and hydrochloric acid. We are committed to supplying the highest quality products and services to our customers, providing a safe and healthy workplace for our employees and contributing to the quality of life in the communities where we operate. This commitment is made possible through our dedicated people, consistent products, continued protection of the environment and ongoing investments in new product development, quality control systems and safe, modern and energy-efficient production facilities. Formosa Plastics is a privately held company headquartered in Livingston, New Jersey. Our core business, producing plastic resins and petrochemicals, takes place at three wholly-owned chemical manufacturing subsidiaries located in Delaware City, Delaware, Baton Rouge, Louisiana and Point Comfort, Texas.Founded in 1978, Formosa Plastics Corporation, U.S.A. (Formosa Plastics) is a growing, vertically-integrated supplier of plastic resins and petrochemicals. With annual revenues of more than $5 billion, we employ over 2,800 people who operate 20 production units in six business divisions - Olefins, Polyolefins, Vinyl, Specialty Polyvinyl Chloride, Chlor-Alkali, and Oil & Gas.\r\n\r\nFormosa Plastics offers a full line of polyvinyl chloride, polyethylene and polypropylene resins, caustic soda and other petrochemicals that deliver the consistency, performance and quality that customers demand. We market our polypropylene and polyethylene resins under the Formolene® tradename; we market our suspension PVC and specialty (dispersion) PVC resins under the Formolon® tradename. We also produce and sell caustic soda, ethylene dichloride, commercial bleach and hydrochloric acid.\r\n\r\nWe are committed to supplying the highest quality products and services to our customers, providing a safe and healthy workplace for our employees and contributing to the quality of life in the communities where we operate. This commitment is made possible through our dedicated people, consistent products, continued protection of the environment and ongoing investments in new product development, quality control systems and safe, modern and energy-efficient production facilities.\r\n\r\nFormosa Plastics is a privately held company headquartered in Livingston, New Jersey. Our core business, producing plastic resins and petrochemicals, takes place at three wholly-owned chemical manufacturing subsidiaries located in Delaware City, Delaware, Baton Rouge, Louisiana and Point Comfort, Texas.

Job DescriptionTitle: Quality Assurance (QA) Supervisor Reports to: Quality Manager or Head of Quality Department: Quality Assurance Responsibilities: • Oversee Quality Systems Modules for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc., • Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups)., • Train and supervise document control/review personnel; batch release personnel, accurate record of approved, quarantined, rejected products., • Lead the review, release and compliance of materials, FG, bulk and intermediates where applicable, to support customer requirements., • Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, HC, EPA, OSHA, ISO 13485:2016)., • Familiar with US FDA OTC drug regulations, including data integrity requirements., • Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods., • Ensures that review of in-process activities in both Manufacturing and Warehouse areas is conducted by QA inspectors for conformance to specifications; follow up on out-of-specifications including non conformances., • Participates in In-process Quality in-house and outside training program., • Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations., • Assist in interpreting and/or developing of customer specifications and requirements for approved formulas., • Assists in establishing production and assembly inspection information sheets and documentation as required., • Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Assembly in-process Specifications., • Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness., • Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions., • Reviews of QA Inspection reports daily for correctness and completeness., • Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed., • Maintains awareness and compliance with safety regulations in performing job duties., • Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas., • Assist in the review and release of bulk and finished products, when applicable., • Perform supplier and vendor audits, as well as, Mock recall and internal audits., • Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance., • Support formal drug stability program, bulk hold studies, and product compatibility by co-ordinating samples submission, testing, result retrieval and program review., • Maintains files and database of customer-approvals and documents as evidence of authenticity., • Effects changes to specification sheets as approved through proper change control requests., • Support Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications., • Maintains copies of approved change controls as applicable to product specification updates/revisions., • Under the supervision of Quality Manager, review and approved formulas, specifications and procedures., • Communicates new and updated SOPs to all employees at EWL. Qualifications: • Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession)., • Three + years industry or related experience in cosmetic, device, food, or pharma., • Experience/Knowledge of US FDA OTC regulations - a plus., • Previous inspecting, auditing or manufacturing experience - a plus., • Data analysis, specification development skills., • Computer literate and effective communication skills., • Ability to lift and carry up to 10-15 pounds.Compensation & Benefits:, • Pay range: $60,000 - $65,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match obtLtIxvhl

Job Description ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients' lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve. WHY JOIN OUR FAST-GROWING TEAM At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team! ESSENTIAL JOB FUNCTIONS The Field Clinical Representative provides technical and clinical expertise, educational and field support to ensure the safe adoption of the Inspire therapy and products. The FCR is responsible for working with customers, physicians, clinic staff and Inspire field staff to drive procedural and practice success. OPPORTUNITIES YOU WILL HAVE IN THIS ROLE • Provide technical support during implant procedures and at device activation., • Maintain credentials enabling access to assigned hospitals and clinics., • Provide technical leadership and education in assigned region to account clinical staff., • Provide post-training follow up including procedural reviews, in servicing and support., • Assist customers in device troubleshooting., • Collaborate with sales personnel on appropriate training/support for targeted customers., • Proactively disseminate peer-reviewed scientific and clinical information to customers and assigned sales team as needed., • Provide technical expertise for assigned regional education and training activities., • Stay current on relevant scientific publications and clinical evidence. WHAT YOU CAN BRING TO OUR GREAT TEAM Required: • Bachelors' degree and 2+ years of related clinical, healthcare or medical device industry experience (OR) Bachelor's degree and 1+ years applicable Inspire experience (OR) an Associates' degree or Professional Certification and 5+ years of related clinical/healthcare or medical device industry experience., • Ability to communicate and collaborate effectively in a clinical setting., • Strong computer skills with MS office including PowerPoint and Excel., • Problem solving/trouble shooting skills., • Degree in Nursing, Engineering, Science or technical discipline., • Previous Operating Room (surgical) coverage with implantable devices. #LI-REMOTE The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level. Salary$100,000—$130,000 USD BENEFITS AND OTHER COMPENSATION Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered): • Multiple health insurance plan options., • Employer contributions to Health Savings Account., • Dental, Vision, Life and Disability benefits., • 401k plan + employer match., • Identity Protection., • Flexible time off., • Tuition Reimbursement., • Employee Assistance program., • All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program. Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis. Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com Inspire Medical Systems participates in E-Verify.

Job 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: 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: