Quality Assurance Operations Engineer

Job Code:

Q1047

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Post Date:

November 23, 2021

JOB DESCRIPTION

The Quality Assurance Operations (QA Ops) Supervisor is responsible for the overall performance of a team of Quality Assurance Specialists for Lot Disposition and for Quality Assurance on the Floor at Matica Biotechnology College Station TX.  The qualified candidate will ensure that the staff is appropriately scheduled and trained to support ongoing manufacturing needs.  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, Cell and Gene Therapy experience preferred