Quality Assurance Operations Specialist

Philadelphia, PA - USA

Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

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

Bachelors degree in a scientific discipline
35 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

Required Skills:

QA quality assurance CAPA batch records pharmaceutical GMP biotechnology life sciences

Required Education:

Bachelors Degree

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 Duratio...