Quality Assurance Specialist Clinical Trial Supply

JUPITER RESEARCH SERVICES INC; Edison (NJ); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Highly enriched & healthy work environment

Excellent growth opportunities

Competitive Pay

Career Advancement

Job summary

A leading clinical supply solutions firm in New Jersey is seeking an experienced Quality Assurance Specialist to oversee the quality of goods and services. The ideal candidate will ensure compliance with regulatory standards while performing regular inspections and implementing QA procedures. Strong communication skills and a detail-oriented approach are essential for this role. Opportunities for growth in Quality and Operations await the right candidate.

Qualifications

• 2–5 years of experience in Quality Assurance within Clinical Trial Supply, Pharmaceutical, Biotech, or related field.
• Strong understanding of GMP, GDP, GCP, and clinical supply chain processes.
• Experience with deviations, CAPA, change control, and QA release.

Responsibilities

• Oversee quality of goods and services provided by the company.
• Perform routine inspections and implement QA policies.
• Support compliance with FDA, EU-GMP, and other regulations.

Skills

Attention to detail

Verbal communication

Written communication

Problem-solving skills

Education

Bachelor’s degree in Life Sciences

Tools

Power BI

SharePoint QMS

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

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.

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.

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.

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.

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.

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.