Quality Assurance Specialist - Clinical Trial Supply

Quality Assurance Specialist - Clinical Trial Supply

Join to apply for the Quality Assurance Specialist - Clinical Trial Supply role at JUPITER RESEARCH SERVICES INC

We are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will oversee the quality of goods and services the company provides. You will perform routine inspections, implement QA policies and procedures, and identify workflow issues. The ideal candidate is an excellent verbal and written communicator with strong attention to detail.

The Quality Assurance Specialist – Clinical Trial Supply plays a critical role in ensuring the quality, safety, integrity, and compliance of clinical trial materials throughout their lifecycle—from receipt and storage to packaging, labeling, distribution, and returns. The role supports GxP operations, oversees Quality System activities, and collaborates cross‑functionally with Operations, Warehouse, Packaging, Project Management, and external suppliers/CROs to maintain compliance with FDA, EU-GMP, GDP, ICH-GCP, DSCSA and internal JRS standards.

The QA Specialist ensures that all products and processes meet regulatory and customer expectations while supporting JRS’s mission.

• Quality Systems & Compliance
  • Ensure compliance with GMP, GDP, GCP, ICH, FDA, EMA, MHRA, TGA, CDSCO and JRS internal SOPs.
  • Review, approve, and maintain controlled documents including SOPs, Work Instructions, Forms, Batch Records, Labeling Specs, and Packaging Records.
  • Support implementation and continuous improvement of Quality Management Systems (QMS) including Deviation Management, CAPA, Change Control, Training, and Document Control.
  • Participate in internal audits, customer audits, vendor qualifications, and regulatory inspections.
  • Perform QA review and approval of incoming clinical supplies, packaging and labeling activities, storage and temperature monitoring records, distribution documentation.
  • Verify completion and accuracy of Line Clearance, Batch Packaging Records (BPR), and Label Control Logs.
  • Review and approve traceability files, CoA/CoC, pedigrees, and other regulatory documents.
  • Lead or support investigations for temperature excursions, packaging or labeling discrepancies, shipment issues, or complaints.
  • Perform root cause analysis (RCA), risk evaluation, and implement effective CAPAs.
  • Support supplier qualification through review of licenses, ISO certifications, Quality Agreements, questionnaires, and risk assessments.
  • Collaborate with customers to ensure project‑specific quality requirements are met.
  • Maintain updated Quality and Technical Agreements (QTA) with clients and suppliers.
  • Deliver and maintain training programs for QA and Operations teams on GDP/GMP compliance, SOP revisions, packaging and labeling quality requirements, and temperature control best practices.
  • Participate in continuous improvement initiatives to enhance operational efficiency and compliance.

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field.
• 2–5 years of experience in Quality Assurance within Clinical Trial Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/GDP warehouse environment.
• Strong understanding of GMP, GDP, GCP, DSCSA/EPCIS, ICH guidelines, and clinical supply chain processes.
• Experience with deviations, CAPA, change control, labeling review, packaging operations, and QA release.
• Experience working with temperature‑controlled logistics (2–8°C,
  -20°C, CRT).
• Knowledge of comparator sourcing workflows and global distribution practices.
• Familiarity with Quality Agreements, Supplier Qualification, and Vendor Audits.
• Experience with Power BI, SharePoint QMS, and ERP/WMS systems.
• Certification in GMP/GDP/GCP (optional but advantageous).
• Strong attention to detail and documentation accuracy.
• Excellent communication and problem‑solving skills.
• Ability to work cross‑functionally and manage multiple priorities.
• Proactive, organized, and committed to quality and compliance.
• Ability to make decisions based on risk, data analysis, and regulatory expectations.
• Work in a rapidly growing organization focused on resilient clinical…