Quality Assurance Specialist Clinical Finished Goods

2 weeks ago


Rahway, New Jersey, United States Piper Companies Full time

Piper Companies is currently seeking a Quality Assurance Specialist, Clinical Finished Goods for a hybrid-based opportunity in a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.

Responsibilities of the Quality Assurance Specialist, Clinical Finished Goods

  • Electronic batch record review of finished clinical goods to ensure clinical supplies are in compliance with cGMP and SOPs
  • Clinical supplier specifications, labeling, storage, etc.
  • Review of Electronic records for regulatory submissions (IND or CTA)
  • Areas of focus will include biologics, vaccines, combination products, etc.

Qualifications of the Quality Assurance Specialist, Clinical Finished Goods

  • 2-5 years of quality assurance or clinical development experience in a GMP environment
  • Experience within biologics and/or vaccines is preferred
  • Strong understanding of SAP, Trackwise, Midas, Veeva, and QMAS is preferred
  • Bachelor's Degree in life science related field required

Compensation for the Quality Assurance Specialist, Clinical Finished Goods

  • Salary Range: $32.00 - $38.00 / hour
  • Benefits: Medical, Dental, Vision, 401k match, Paid Holidays, and PTO
  • Long Term Contract Opportunity
  • Hybrid Onsite / Work From Home Schedule

Keywords: pharmaceutical, pharma, clinical supplies, regulatory review, batch record review, batch disposition, GMP, cGMP, current good manufacturing process, good manufacturing process, QA, quality assurance, clinical development, clinical quality, vaccines, biologics, electronic batch record, SOPs, specification, labeling, SAP, trackwise, midas, veeva, QMAS



  • Rahway, New Jersey, United States Zachary Piper Solutions Full time

    Zachary Piper Solutions is currently seeking a Quality Assurance Specialist, Clinical Finished Goods for a hybrid-based opportunity to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.ResponsibilitiesReview electronic batch records of finished clinical goods to ensure compliance with cGMP and SOPs.Manage...


  • Rahway, New Jersey, United States Zachary Piper Solutions Full time

    Zachary Piper Solutions is currently seeking a Quality Assurance Specialist, Clinical Finished Goods for a hybrid-based opportunity in a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.Key Responsibilities:Electronic batch record review of finished clinical goods to ensure clinical supplies are in compliance...


  • Rahway, New Jersey, United States Piper Companies Full time

    Piper CompaniesWe are seeking a highly skilled QA Specialist, Clinical Finished Goods to join our team in Rahway, New Jersey.ResponsibilitiesReview electronic batch records to ensure compliance with cGMP and SOPsVerify clinical supplier specifications, labeling, and storageReview electronic records for regulatory submissions (IND or CTA)Focus on biologics,...


  • Rahway, New Jersey, United States Piper Companies Full time

    Piper Companies is seeking an experienced Quality Assurance Specialist to oversee and ensure regulatory compliance in cell therapy manufacturing.Key Responsibilities:• Conduct thorough reviews of clinical/commercial electronic batch records and documentation for completeness and accuracy.• Correct and revise documentation as needed to ensure compliance...


  • Rahway, New Jersey, United States AA2IT Full time

    Job Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at AA2IT. The successful candidate will be responsible for managing deviations and customer complaints, ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Review and approve deviation reports and...


  • Rahway, New Jersey, United States AA2IT Full time

    {"Responsibilities": "The Quality Assurance Specialist for Small molecule is responsible for managing deviations and customer complaints, including coordination, review, and approval of deviations and complaint investigations. Key activities include reviewing and approving deviation reports, notifying external manufacturing sites of customer complaints,...


  • Rahway, New Jersey, United States Tekfortune Inc Full time

    Tekfortune Inc Job DescriptionWe are seeking an experienced TOSCA QA Lead to join our dynamic team.The ideal candidate will have a solid background in software quality assurance, with expertise in TOSCA automation testing.The TOSCA QA Lead will be responsible for leading the testing efforts, developing automated test scripts, and ensuring the delivery of...


  • Rahway, New Jersey, United States Piper Companies Full time

    Piper Companies is seeking a highly skilled Clinical Supplies Quality Assurance Specialist to join their team in Rahway, NJ.Key Responsibilities:• Conduct thorough reviews of electronic batch records to ensure compliance with cGMP and SOPs.• Verify clinical supplier specifications, labeling, and storage procedures.• Review electronic records for...


  • Rahway, New Jersey, United States Omni Inclusive Full time

    Senior Quality Assurance ManagerWe are seeking an experienced Senior Quality Assurance Manager to lead our testing efforts. The ideal candidate will have a solid background in software quality assurance, with expertise in TOSCA automation testing.Key Responsibilities:Develop and implement test strategies and plansLead the testing efforts and ensure the...


  • Rahway, New Jersey, United States Omni Inclusive Full time

    Key Responsibilities:We are seeking a skilled TOSCA Testing Expert to lead our testing efforts and develop automated test scripts. The ideal candidate will have a strong background in software quality assurance and expertise in TOSCA automation testing.Key Requirements:Proven experience as a QA Lead with a focus on TOSCA automationStrong understanding of...


  • Rahway, New Jersey, United States Collabera Full time

    Clinical Operations Specialist - PaymentsWe are seeking a highly skilled Clinical Operations Specialist - Payments to join our team at Collabera. As a key member of our clinical operations team, you will be responsible for supporting site payment-related activities for clinical trials, ensuring accurate and efficient processing of...


  • Rahway, New Jersey, United States Eateam Full time

    Key Responsibilities:As a Tosca Automation Specialist at Eateam, you will lead the testing efforts, develop automated test scripts, and ensure the delivery of high-quality software products. Your expertise in TOSCA automation testing will be crucial in driving our software quality assurance initiatives forward.Requirements:Proven experience as a QA Lead with...


  • Rahway, New Jersey, United States NavitsPartners Full time

    Job OverviewWe are seeking a skilled Clinical Documentation Specialist to join our team at NavitsPartners. This role will support the operational aspects of procedural documentation management and advise on documentation strategy within the Global Regulatory Affairs & Clinical Safety (GRACS) organization.Key ResponsibilitiesDevelop and manage integrated...


  • Rahway, New Jersey, United States RWJBarnabas Health Full time

    Job SummaryThe Clinical Care Technician provides care in the healthcare system within the scope of practice defined by regulatory standards and assures awareness of ethical standards of practice as defined by the ANA code of ethics. The technician assures safety in practice and is inclusive of the principles of evidence-based practice by maintaining a...


  • Rahway, New Jersey, United States Quality Carriers Full time

    Job Title: Class A CDL OTR Company Driver Job Summary: We are seeking a highly skilled Class A CDL OTR company driver to join our team at the Rahway, NJ 137 Terminal. As a driver for Quality Carriers, you will be responsible for transporting goods safely and efficiently across the country. Responsibilities: * Operate a tractor trailer to transport goods...


  • Rahway, New Jersey, United States eTeam Full time

    Clinical Trial Payment Coordinator Job Description We are seeking a highly skilled Clinical Trial Payment Coordinator to join our team at eTeam. The ideal candidate will have a strong understanding of clinical trial site payments and be able to provide support for US and rest of the world site payment-related activities. Key Responsibilities: Knowledge of...


  • Rahway, New Jersey, United States NutraCo Full time

    NutraCo Clinical Nutritionist Job DescriptionWe are seeking a compassionate and driven Registered Dietitian to join our team at NutraCo, a leading provider of Clinical Nutrition Services to Long Term Care facilities across the United States.Key Responsibilities:Provide compassionate care and support to residents, focusing on their nutritional needs and...


  • Rahway, New Jersey, United States Incredible Health Full time

    Job Title: Clinical Nurse CoordinatorIncredible Health is actively hiring for a Clinical Nurse Coordinator position in the Rahway, NJ area. This role involves coordinating patient care services, managing nursing staff schedules, and assisting in the development of nursing protocols.Responsibilities:Coordinate patient care services by liaising with...


  • Rahway, New Jersey, United States Incredible Health Full time

    Incredible Health is actively hiring for a Clinical Nurse Coordinator in the Rahway, NJ area.We are seeking a skilled and experienced nurse to join our team. The ideal candidate will have a strong background in clinical nursing and excellent leadership skills.Key Responsibilities:Coordinate patient care services by working closely with physicians, nurses,...


  • Rahway, New Jersey, United States RWJBarnabas Health Full time

    Job Title: Diagnostic Imaging SpecialistJob Summary:We are seeking a skilled Diagnostic Imaging Specialist to join our team at RWJBarnabas Health. As a Diagnostic Imaging Specialist, you will be responsible for performing high-quality diagnostic sonographic exams and vascular studies on patients of all ages.Key Responsibilities:Perform diagnostic sonographic...