Operational Quality Specialist

The Operational QA Specialist provides Quality Assurance oversight for GMP manufacturing and support operations, including Upstream and Downstream Bulk Drug Substance (BDS) Manufacturing, Warehouse, Laboratories, and Facilities. This role is responsible for ensuring compliance with applicable regulatory requirements, internal quality standards, and site procedures while supporting the timely release of products and continuous improvement initiatives.

Key Responsibilities

• Provide Quality Assurance oversight for GMP manufacturing operations, warehouse activities, laboratories, and facility support functions.

• Conduct routine area walkthroughs, rapid response activities, and process assessments to ensure compliance with GMP requirements.

• Review executed manufacturing batch records, including solution preparation and Bulk Drug Substance production records.

• Review and approve GMP documentation, including:

  • Standard Operating Procedures (SOPs)

  • Equipment logbooks

  • Cleaning records

  • Glass wash and autoclave records

  • Facility and process documentation

• Review Environmental Monitoring (EM) and water system data to ensure compliance with established quality standards.

• Support investigations, deviations, CAPAs, and change control activities in partnership with QA leadership and cross-functional teams.

• Support internal audits, regulatory inspections, and inspection readiness activities by ensuring documentation is complete, accurate, and reviewed in a timely manner.

• Collaborate across multiple value streams to drive continuous improvement and strengthen the site's quality culture.

• Utilize and promote operational excellence tools and GPS standards, including:

  • 5S

  • Standard Work

  • Problem Solving

  • Gemba Walks

  • Process Confirmation

  • Performance Management

• Support organizational objectives focused on Zero Accidents, Zero Defects, and Zero Waste.

• Partner with cross-site and cross-functional teams to improve product disposition timelines and overall operational performance.

• Represent Quality Assurance on product teams, project teams, governance forums, and cross-functional working groups.

• Perform additional duties and special projects as assigned.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or a related scientific discipline.

• Experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.

• Strong knowledge of cGMP regulations, quality systems, and regulatory requirements.

• Experience with deviations, CAPAs, change controls, investigations, and batch record review.

• Strong communication, collaboration, and problem-solving skills.

• Ability to work effectively in a fast-paced manufacturing environment and across multiple functional areas.

Preferred Qualifications

• Experience supporting biologics or cell culture manufacturing operations.

• Experience with regulatory inspections and audit readiness activities.

• Lean Manufacturing or Operational Excellence experience, including continuous improvement methodologies.