Pharma Manufacturing QA Specialist - QASP 25-20336 job at NavitsPartners Durham, NC, US

Job Description

Job Title: Pharma Manufacturing QA Specialist

Location: Durham, NC 27712 (100% Onsite)

Duration: 12 Months

Rate: $55/hr on W2

Qualifications:

Bachelor’s degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field
Minimum 5 years of experience in the Pharmaceutical Industry
Expertise in regulatory expectations for manufacturing and testing of sterile pharmaceutical products
Experience in quality assurance oversight of sterile manufacturing, process validation, and/or technology transfer
At least 3 years of experience with the development, review, and approval of:
- User Requirements Specifications (URS)
- Factory Acceptance Testing (FAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
  for pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities

Responsibilities:

Support manufacturing site assessments and preparation for Pre-Approval Inspections (PAI) by regulatory agencies
Independently manage project assignments under the Quality Assurance Organization
Provide QA oversight for GMP documentation, including:
- Quality Agreements
- Quality Risk Assessments
- URS, FAT, IQ, OQ, PQ
- Change management and manufacturing/batch documentation
Ensure compliance with cGMP regulations and Quality Management System requirements
Review and approve qualification and compliance documentation for manufacturing equipment, including:
- Isolators
- Restricted access barriers
- Incubators
- Washers and autoclaves
- Formulation vessels
- Lyophilizers
Review and approve master batch records, technical protocols, investigations, change controls, SOPs, and validation reports
Collaborate cross-functionally and consult with senior management on complex decisions

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