Quality Assurance Operations Supervisor

Job Code:

Q1047

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JOB DESCRIPTION

The Quality Assurance Operations (QA Ops) Supervisor is responsible for supervising operations in a GMP Manufacturing Facility at Matica Biotechnology, College Station TX. This individual supervises the work of QA Disposition Specialists and QA on the Floor Specialists in accordance with Matica’s policies, standards, procedures and Global cGMP. The QA Ops Supervisor will also ensure that all work generated by the team is accurate, complete and in conformance with Matica policies and procedures. 

RESPONSIBILITIES

The Quality Assurance Supervisor shall have oversight of the following:

  • Deviation Management

  • Batch Record Review

  • Manufacturing Quality

  • Incoming Quality

  • Ensure appropriate tracking and timely resolution of quality issues (Deviations, Corrective/Preventive Actions and Change Controls).

  • Ensure timely review / approval of basic and technical documentation to include, but not limited to, Standard Operating Procedures, Work Instructions, Batch Production Records and QC data review and approval.

  • Provide support of regulatory inspections, customer and internal audits.

  • Maintain visibility and investigate regulatory compliance requirements, guidelines, and trends.

  • Ensure self, and team, have no overdue training, or site actions.

  • Ensure Appropriate Organization and Control of In Process Documentation

  • Other job functions as assigned.

QUALIFICATIONS

  • Bachelor’s degree in a life science with 5+ years of experience in Quality Assurance supporting biotech or pharmaceutical products; OR Master’s degree in a life science with 4 years of experience in Quality Assurance supporting biotech or pharmaceutical products.

  • A minimum of 4 years of cGMP experience in Cell and Gene Therapy

  • Certified Quality Auditor