Quality Assurance Specialist - Clinical Trial Supply

Jupiter Research Services•Edison, NJ

26d

About The Position

We are seeking an experienced Quality Assurance Specialist to join our team. In this role, you will be responsible for overseeing the quality of goods and services our company provides. You will perform routine inspections, implement quality assurance policies and procedures, and identify any 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. This 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 to deliver reliable, resilient, and high-quality clinical supply solutions worldwide.

Requirements

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.

Nice To Haves

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).

Responsibilities

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 (comparator drugs, IMPs, ancillary supplies), Packaging and labeling activities, Storage and temperature monitoring records, Distribution documentation including shipping records, AWBs, and temperature logger data.
Verify completion and accuracy of Line Clearance, Batch Packaging Records (BPR), and Label Control Logs.
Review and approve EPCIS/DSCSA traceability files, CoA/CoC, pedigrees, and other regulatory documentation.
Lead or support investigations for: Temperature excursions, Packaging or labeling discrepancies, Shipment issues, Supplier or customer complaints.
Perform root cause analysis (RCA), risk evaluation, and implement effective CAPAs.
Support supplier qualification by reviewing: GMP/GDP licenses, ISO certifications, Quality Agreements (QTA), Questionnaires and risk assessments.
Collaborate with customers to ensure project-specific quality requirements are met.
Ensure accurate completion of QA documentation related to: Clinical supply release, Temperature-controlled shipping, Storage of controlled and non-controlled materials, Destruction, return, and reconciliation.
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, Temperature control best practices.
Participate in continuous improvement initiatives to enhance operational efficiency and compliance.