More jobs:
Quality Assurance Operations Specialist
Job in
Philadelphia, Philadelphia County, Pennsylvania, 19104, USA
Listed on 2026-02-03
Listing for:
Dawar Consulting, Inc.
Full Time
position Listed on 2026-02-03
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
Our client, a world leader in biotechnology and life sciences, is looking for a "Quality Assurance Operations Specialist" based out of Philadelphia, PA.
Job Duration:
Long Term Contract (Possibility Of Extension)
Pay Rate : $42/hr on W2
Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K
Duration:
Long term contract (Possibility of further extension)
The Quality Assurance Operations Specialist provides quality oversight and technical support for manufacturing operations in a regulated environment. This role ensures compliance with cGMP requirements through review of batch records, deviations, investigations, change controls, CAPAs, and material release activities, supporting both clinical and commercial manufacturing.
Key Responsibilities
- Provide QA oversight during manufacturing activities
- Review executed batch records, deviations, and product disposition decisions
- Open, manage, and close deviations, investigations, change controls, and CAPAs
- Review QC testing records and OOS investigations
- Review, write, revise, and approve SOPs and technical documentation
- Perform material inspection and release; review vendor CoCs/Co As
- Compile and analyze quality metrics and trending data
- Support Quality Management System (QMS) integration and improvement projects
- Support Quality Risk Management and Change Control governance
- Prepare CoCs and CoAs for clinical and commercial materials
- Bachelor's degree in a scientific discipline
- 3-5 years of experience in a regulated manufacturing environment
- Working knowledge of Quality Systems (Deviations, CAPA, Change Control)
- Strong technical writing and communication skills
- Knowledge of cGMP regulations and guidelines
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