Pharmaceutical Quality Assurance Specialist

About the Role:

We are seeking a Quality Assurance professional with a minimum of a BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years of experience in the Pharmaceutical Industry.

The ideal candidate must have a working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products, with experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.

Responsibilities:

Assess and prepare manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.

Independently manage project assignments reporting to the Quality Assurance Organization.

Demonstrate strong interpersonal, communication, negotiation, and persuasion skills.

Provide immediate project support on the review and approval of commissioning and qualification (C&Q) documents.

Support QA activities including review and approval of GMP documentation, change management, and manufacturing/batch documents.

Ensure project compliance with cGMP, regulations, and the Company’s Quality Management System.

Focus on Qualification and Compliance covering Manufacturing Equipment. Review and approve master batch records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports.

Consult with next-level manager on complex decisions as needed.

Education Qualification:

Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent).

Required Skills:

Minimum 5 years of experience in the Pharmaceutical Industry.

Knowledge of regulatory expectations for sterile pharmaceutical products.

Experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.

3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment.

Strong relationship building skills.

Ability to work independently and manage project assignments effectively.

Pay Range: $45 - $50/hr.