Senior Quality Assurance Specialist

5 days ago

Raleigh, North Carolina, United States Mantell Associates Full time $80,000 - $120,000 per year

Mantell Associates is partnered with a leading Pharmaceutical organisation, who is seeking an experienced Senior QA Specialist to join their Quality Assurance team on a contract basis.

This role will be pivotal in maintaining GMP compliance, supporting manufacturing operations and ensuring product quality across site activities on the East Coast.

Senior QA Specialist - Responsibilities:

  • Review and approve GMP documentation, including batch records, SOPs, deviation reports, change controls, and quality logs to ensure accurate and compliant release practices
  • Lead investigation of quality events (deviations, non-conformances, out-of-specifications) and coordinate root cause analysis and CAPA implementation
  • Support supplier and vendor qualification activities; review vendor documentation and ensure alignment with site quality standards
  • Collaborate closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Technical Operations to identify and mitigate quality risks and support continuous improvement initiatives
  • Prepare for and support internal audits and external inspections; maintain readiness by ensuring documentation integrity and audit traceability
  • Monitor and report on key quality metrics (deviation trends, CAPA backlog, audit findings) and provide actionable recommendations to senior leadership
  • Participate in change control reviews, validation hand-offs, and project quality oversight to ensure effective execution and compliance

Senior QA Specialist - Requirements:

  • At least 4-6 years of experience in Quality Assurance within a GMP pharmaceutical manufacturing environment
  • Strong knowledge of regulatory requirements (FDA, GMP) and quality systems (deviation management, CAPA, change control, batch record review)
  • Excellent investigative skills with hands-on experience in executing root cause analysis and implementing corrective/preventive actions
  • Effective collaboration and communication skills, able to work cross-functionally with multiple stakeholders in operations, regulatory and technical teams
  • Strong attention to detail and documentation capabilities, with proven ability to maintain quality under operational constraints
  • Based on the East Coast USA, with the ability to be on-site full-time for the duration of the contract

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us

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