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Quality Assurance Specialist - Clinical Trial Supply

Jupiter Research ServicesEdison, New Jersey

$40,000 - $55,000 / year

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Overview

Schedule
Full-time
Career level
Senior-level
Remote
On-site
Compensation
$40,000-$55,000/year
Benefits
Career Development
Health & Wellness Programs

Job Description

Benefits/Perks
  • Highly enriched & healthy work environment
  • Excellent growth opportunities
  • Competitive Pay
  • Career Advancement
Job Summary
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. 
Position Summary
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.
Key Responsibilities
1. 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.
2. Clinical Supply Chain Quality Oversight
  • 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.
3. Investigations & Deviation Management
  • 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.
4. Vendor & Customer Quality Support
  • 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.
5. Documentation & Regulatory Support
  • 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.
6. Training & Continuous Improvement
  • 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.
Required Qualifications
  • 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.
Preferred Qualifications
  • 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).
Core Competencies
  • 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.
Why Join Jupiter Research Services?
  • Work in a rapidly growing organization focused on resilient clinical supply chain solutions.
  • Gain exposure to global clinical trials, high-impact projects, and innovative supply models.
  • Contribute to a compliance-driven organization with strong customer and patient-centric values.
  • Opportunities for growth in Quality, Operations, Regulatory, and Project Management.
Compensation: $40,000.00 - $55,000.00 per year

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FAQs About Quality Assurance Specialist - Clinical Trial Supply Jobs at Jupiter Research Services

What is the work location for this position at Jupiter Research Services?
This job at Jupiter Research Services is located in Edison, New Jersey, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Jupiter Research Services?
Candidates can expect a pay range of $40,000 and $55,000 per year.
What employment applies to this position at Jupiter Research Services?
Jupiter Research Services lists this role as a Full-time position.
What experience level is required for this role at Jupiter Research Services?
Jupiter Research Services is looking for a candidate with "Senior-level" experience level.
What benefits are offered by Jupiter Research Services for this role?
Jupiter Research Services offers following benefits: Career Development and Health & Wellness Programs for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Jupiter Research Services?
You can apply for this role at Jupiter Research Services either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.