Quality Assurance Operations Specialist

Dawar Consulting • Philadelphia, PA

9h

About The Position

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.

Requirements

• 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

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/CoAs
• 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

Benefits

• Medical
• Dental
• Vision
• Paid Sick leave
• 401K

What This Job Offers

• Career Level: Mid Level