Pharma Manufacturing QA Specialist - QASP 25-20336 Job at NavitsPartners, Raleigh, NC

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  • NavitsPartners
  • Raleigh, NC

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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