About The Position

The Quality Assurance Final Container Release group is seeking a results driven Supervisor who demonstrates high energy, strong initiative and a consistent record of high performance. The ideal candidate is a highly organized self‑starter who thrives on responsibility, brings energy to daily operations, and consistently delivers results. They are comfortable working independently while effectively leading and motivating others toward company goals and expectations. They can adapt quickly to the fast-paced, dynamic environment associated with supplying biological products to the market. The Quality Assurance Supervisor II/III is a fully qualified professional who requires minimal supervision and is responsible for performing tasks and making decisions related to batch release. He/she may also participate in cross-functional teams of varying scope and provide leadership and guidance to others.

Requirements

  • BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience (for Supervisor II-QA)
  • BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 6 years relevant experience, or equivalent combination of education and experience (for Supervisor III-QA)

Responsibilities

  • Supervision of a group of employees performing tasks and assignments related to final batch release for market distribution
  • Motivate and assist teams in the prioritization or weekly, monthly, quarterly and yearly batch release goals
  • Identify opportunities, solve problems and improve processes related to final batch release.
  • Proactively identify and address issues before they impact final batch release dates.
  • Create and edit templates for batch Certificates of Analysis for released batches.
  • Create and maintain lists of reprocessed, reworked, rejected batches for Inspections and audits
  • Create lists of batches released for use in APRs and audits/inspections.
  • Ensure product batches meet the release requirements prior to final release
  • Upload Certificates of Analysis to PediGri
  • Maintain and make edits to the Viral Risk Assessment computer program used for batch release
  • Maintain various excel spreadsheets for tracking batch releases
  • Troubleshoot SAP issues
  • Participation in project meetings related to batch release
  • Follow cGMP and department safety practices.
  • Demonstrate high levels of values and integrity.
  • Makes sound quality decisions with minimal guidance
  • Represent QA FC Release at meetings and projects
  • Perform advanced roles related to SAP Batch Release and SAP Quality Module
  • Maintain QA Release SOPs and Checklists
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