Quality Assurance Operations Specialist

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/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
  

Qualifications

• 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
  

If interested, please
send us your updated resume at

[email protected]/[email protected]