Quality Assurance Specialist


  • Bachelor of Science in Chemistry, Biochemistry, Industrial Pharmacy or related scientific field, or foreign equivalent degree, or comparable level of technical training through formal education and/or industrial experience.
  • 2 – 5 years’ experience in a cGMP quality, regulatory, and/or chemical manufacturing environment, with applied knowledge of GMP principles across quality disciplines, including but not limited to: Change Control; Training; Investigations; CAPA; Supplier Qualification; ICH stability studies; Method and/or Process Validation.
  • Advanced demonstrated knowledge and proficiency in at least one of the following aspects of pharmaceutical operations:
    • Analytical services, including equipment operation, laboratory data review, and material testing technologies (e.g. HPLC, GC, FTIR, KF, UV, TOC, wet chemistry)
    • Manufacturing, including batch processing, equipment maintenance and calibration, batch record review


  • Proactively perform Quality Assurance function in full compliance with current Good Manufacturing Practices applying regulations ICH Q7 and 21 CFR 211.
  • Consistent contribution to daily Quality Assurance operations, including but not limited to the following:
    • Product release, including data and batch record review
    • Review, editing and approval of controlled quality documentation
    • Quality investigations
    • Review of analytical method development and validation
    • Change control, including documentation, equipment and process changes
    • Inspection / internal audits of the facility to ensure real-time GMP compliance
    • Supplier Qualification, including external auditing as needed
    • Corrective and Preventative Action program
    • Customer Complaints
    • Training program
  • Assist QA management in efforts at continuous improvement of the quality program, including but not limited to the following:
    • Advocate for quality compliance throughout the organization
    • Periodic review of critical quality systems
    • Report quality metrics / trending
  • Take a leadership / ownership role in support of one or more critical quality systems, including but not limited to the following:
    • Training: develop and perform training opportunities for PCI personnel in critical quality systems, such as LIR, QI and CAPA
    • Investigations: serve as lead for systemic quality investigations; mentor PCI personnel in growth of investigational skills
    • Process Validation: serve as PCI subject matter expert for validation of manufacturing, analytical or cleaning processes