JUPITER RESEARCH SERVICES INC · 1 month ago
Quality Assurance Specialist - Clinical Trial Supply
Edison, NJ
Full-time
Onsite
Entry, Mid Level
2+ years expJupiter Research Services Inc is seeking an experienced Quality Assurance Specialist to join their team. This role is responsible for overseeing the quality of clinical trial materials, ensuring compliance with regulatory standards, and collaborating with various departments to maintain high-quality clinical supply solutions.
BiopharmaBiotechnologyClinical TrialsHealth CareLogisticsMedical DevicePackaging ServicesPharmaceuticalPrintingSupply Chain Management
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
Qualification
Required
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
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
Preferred
Certification in GMP/GDP/GCP (optional but advantageous)
Benefits
Highly enriched & healthy work environment
Excellent growth opportunities
Competitive Pay
Career Advancement
Company
JUPITER RESEARCH SERVICES INC
Clinical Trial Supplies Management, Clinical Trial Management, Comparator Sourcing, Labeling, Packaging, Warehousing, Logistics
11-50 employees
H1B Sponsorship
JUPITER RESEARCH SERVICES INC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (2)
2022 (3)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-08-29Series C
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