Senior Pharmaceutical Quality Specialist - SPQS 25-22729

Job Title: Senior Pharmaceutical Quality Specialist
Location: Durham, NC 27712 (Fully Onsite)
Duration: 12 Months

Rate: $50.00/hr (W2)

Note: X-Ray Test and TB Test are required – please confirm candidate compliance.

Job Description:

We are seeking a Senior Pharmaceutical Quality Specialist to provide Quality Assurance support for a pharmaceutical manufacturing project. The ideal candidate will have experience preparing sites for Pre-Approval Inspections and ensuring compliance with cGMP and regulatory standards.

Key Responsibilities:

• Provide support for manufacturing site assessments and preparation for Pre-Approval Inspections by regulatory agencies for new product introductions.

• Work independently under the Quality Assurance Organization to manage assigned projects.

• Review and approve commissioning and qualification (C&Q) documents for equipment and facility startup.

• Critically review and approve GMP documentation including:

  • Quality Agreements

  • Quality Risk Assessments

  • User Requirements Specifications (URS)

  • Factory Acceptance Testing (FAT)

  • Installation/Operational/Performance Qualifications (IQ/OQ/PQ)

  • Change Controls, SOPs, Validation Protocols, and Technical Reports

  • Manufacturing and batch records (master and executed)

• Ensure project activities are conducted in compliance with cGMP, regulatory expectations, and internal Quality Management Systems.

• Focus areas include Qualification and Compliance for sterile pharmaceutical manufacturing equipment (e.g., isolators, RABS, lyophilizers, autoclaves, washers, incubators, vessels, etc.).

• Collaborate cross-functionally and consult with management for complex decisions as needed.

Qualifications:

• Bachelor’s degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field.

• Minimum 5 years of experience in the pharmaceutical industry, preferably within Quality Assurance.

• At least 3 years of experience reviewing and approving URS, FAT, IQ/OQ/PQ documents related to pharmaceutical or biotechnology equipment and facilities.

• Hands-on knowledge of sterile product manufacturing, validation, and/or tech transfer.

• Strong interpersonal, communication, and negotiation skills are essential.