Senior Specialist Quality Assurance

Merck • Durham, NC, US • $50 - $55 / hour • 22h ago

The Senior Specialist, Quality Assurance (Level III) provides advanced oversight and leadership in ensuring compliance with cGMP and regulatory requirements in the manufacture and testing of sterile pharmaceutical products. This role requires significant experience in sterile process validation, technology transfer, and regulatory expectations. The position is responsible for quality review and approval of critical documentation, execution of quality audits, and support of regulatory inspection readiness. The Senior Specialist serves as a key partner to cross-functional teams, leveraging strong interpersonal and relationship-building skills to uphold quality standards and ensure successful delivery of sterile pharmaceutical products.

Key Responsibilities:

Review and approve batch records to ensure accuracy and compliance with cGMP.
Review and approve technical protocols, including equipment qualification protocols.
Review and approve deviations, ensuring thorough documentation and resolution.
Execute shop floor quality audits to verify compliance with sterile manufacturing practices.
Provide quality assurance oversight of sterile manufacturing, validation activities, and technology transfers.
Support the assessment and preparation of manufacturing sites for regulatory inspections, including Pre-Approval Inspections (PAIs).
Partner with operations, validation, and technical teams to drive continuous improvement in sterile manufacturing processes.

Skills & Qualifications

Required:

Minimum of a BS degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent scientific discipline.
At least 5 years of experience in the pharmaceutical industry (Associate’s degree with strong relevant experience will also be considered).
Strong working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
Experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.
Demonstrated interpersonal, communication, negotiation, and persuasion skills.
Strong relationship-building ability and effective cross-functional collaboration.

Preferred:

Experience preparing and supporting manufacturing sites for regulatory inspections, including Pre-Approval Inspections (PAIs) for new products.

Education:

Bachelor’s degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent.
Associate’s degree with strong relevant pharmaceutical industry experience may also be considered.

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