Senior Quality Assurance Associate

About the role

Now hiring for a Senior QA Associate to support warehouse, production, and distribution operations. Candidates with In Process Quality Assurance (IPQA) backgrounds encouraged to apply!

Responsibilities

• Lead receipt and inspection of pharmaceutical products for compliance with Good Documentation Practices (GDP), Drug Supply Chain Security Act (DSCSA), and regulatory requirements.
• Verify DSCSA serialization, lot traceability, and chain of custody documentation.
• Identify and manage suspect or illegitimate product reports.
• Monitor warehouse environmental conditions and storage compliance.
• Inspect returned goods for disposition and regulatory compliance.
• Write, revise, and approve QA documentation (SOPs, procedures, work instructions).
• Investigate and resolve deviations and nonconformances.
• Execute QA review and approval of product release documentation.
• Support continuous improvement activities to enhance Quality operations and regulatory compliance.

Requirements

• Minimum B.S. degree, preferably in a scientific field.
• 2-3 years of experience in Quality Assurance or a similar field within the pharmaceutical industry.
• Oracle experience (preferred).
• Good knowledge of Microsoft Office applications.
• Organizational and leadership skills.
• Excellent data collection and analysis skills.
• Keen attention to detail, and critical/logical thinking.
• Strong knowledge of GMP regulations and their application.
• Demonstrated ability to communicate technical information or complex situations clearly.
• Excellent verbal, written, and teamwork communication skills.

Pay

$27 - $29 per hour

Schedule

Monday through Friday, 10:30am to 7:30pm

Work model

Onsite in East Windsor, NJ

Benefits

Eligible employees receive health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.