Senior QA Specialist

Senior QA Specialist

Quality Assurance

Durham, NC, US

Pay Rate Low: 50.00 | Pay Rate High: 55.00

Added - 24/02/2025

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Relocation and sponsorship are not available for this position.

Our client, a prestigious global pharmaceutical leader renowned for its excellence in developing and manufacturing a wide range of high-quality pharmaceutical drugs, life-saving vaccines, and innovative animal health products, is seeking a highly skilled Senior QA Specialist to join their dynamic team.

Location:

Durham, NC

Contract Term:

1 Year (with potential for extension or conversion)

Pay Rate:

$50-55/hr

Qualifications:

Minimum of a BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field, along with at least 5 years of experience in the pharmaceutical industry.

Strong knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.

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

At least 3 years of experience in the development, review, and approval of User Requirements (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities.

Responsibilities:

Preferred experience in assessing and preparing manufacturing sites for Pre-Approval Inspections by regulatory agencies for new products.

Independently manage project assignments while reporting to the Quality Assurance Organization.

Strong interpersonal, communication, negotiation, and persuasion skills are essential for effective relationship building.

Provide immediate support on reviewing and approving commissioning and qualification (C&Q) documents to ensure successful project delivery.

Provide QA support through critical review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, technical documents, change management, and manufacturing/batch records to meet milestone deadlines.

Ensure compliance with cGMP, regulations, and the company’s Quality Management System across all aspects of the project.

Focus on Qualification and Compliance for manufacturing equipment, including isolators, restricted access barriers, incubators, washers, autoclaves, formulation vessels, lyophilizers, and others.

Review and approve master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports.

Provide consultation on complex decisions as needed, collaborating with management for resolution.

Why Join Us?

Ready to take the next step in your career? Apply now and become part of a global leader in the pharmaceutical industry, where you can truly make an impact!

This job description outlines a comprehensive list of desired skills, but not all are required. We encourage candidates with some of the relevant experience to apply. We look forward to learning more about you during the application process.

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INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.