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Quality Assurance Associate III
Job in
Allendale, Bergen County, New Jersey, 07401, USA
Listed on 2026-01-01
Listing for:
Medix™
Full Time
position Listed on 2026-01-01
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist / Manager, Quality Control / Manager
Job Description & How to Apply Below
Location: Allendale
Quality Assurance Associate III - 244917
Responsibilities
- On-site role providing QA oversight for manufacturing operations.
- Review and approve deviations, non-conformance events, change requests, and change controls.
- Audit and approve pre-/post-executed batch records, validation reports, and product/label specifications in compliance with cGMP and internal procedures.
- Prepare release checklists, CoAs, and related documentation to support timely batch disposition.
- Serve as QA liaison with manufacturing, project teams, clients, and regulatory bodies, ensuring quality standards are met and issues are appropriately escalated.
- Write, review, and revise SOPs; lead/participate in audits, inspections, walkthroughs, and process improvement initiatives.
- Represent QA in meetings and act as the single point of contact for designated clients.
- May perform qualified visual inspections of final product when required.
- 5+ years of experience in the biopharmaceutical industry
- Bachelor’s degree in a Science related field preferred
- Strong knowledge of FDA/EU cGMP requirements and QA documentation practices.
- Proficient with Microsoft Office; able to perform accurate calculations and data recording.
- Experienced in reviewing/approving deviations, NCEs, and change controls.
- Skilled in problem-solving, decision-making, and prioritizing competing tasks.
- Effective communicator with strong interpersonal and teamwork abilities.
- Flexible and adaptable to changing priorities and business needs.
- Demonstrated ability to work independently on complex issues while building productive internal/external relationships.
- Associate
- Full-time
- Quality Assurance
- Biotechnology Research and Pharmaceutical Manufacturing
Position Requirements
10+ Years
work experience
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