Quality Specialist (Manufacturing)

We are seeking a Quality Specialist to provide direct quality support to a production area as part of an Integrated Product Team (IPT). This role is key to ensuring product quality and compliance with cGMP and regulatory requirements, working closely with the team on the shop floor to maintain adherence to Good Manufacturing and Documentation Practices.

Key Responsibilities:

• Review and approve Master Batch Records, Electronic Batch Records, and production documentation for compliance with cGMPs.

• Provide quality support on the shop floor, offering guidance to ensure accurate documentation and adherence to compliance standards.

• Review and approve SOPs, Work Instructions, and Controlled Job Aides.

• Support commissioning, qualification, and validation activities for new equipment and facilities.

• Participate in cross-functional projects and continuous improvement initiatives.

• Provide support during internal audits and regulatory inspections.

• Drive quality initiatives, utilizing problem-solving tools to improve operational efficiency.

Requirements:

• Education: Bachelor’s degree in a scientific or engineering field (preferred).

• Experience: Minimum of 5 years in GMP Manufacturing, Quality Assurance, or a similar role in the biotech or pharmaceutical industry.

• Strong understanding of cGMPs, regulatory requirements, and QA operations.

• Proven leadership, communication, and interpersonal skills, with the ability to work in a team environment.

• Experience in GMP documentation review, process validation, and supporting regulatory inspections is preferred.