Quality , Science, Pharmaceutical & Food

QC Micro Team Leader

  • Full Time
  • Remote
  • Limerick
  • 41831247

Summary
Oversees the laboratory quality control testing of in-process samples, sampling of utilities and manages the environmental monitoring programme.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of intermediates (in process) and bulk drug substance in a cGMP regulatory environment. Distribute work load and monitor progress.

• Manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas

• Manages product testing to ensure efficient and compliant operations.

• Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).

• Review and approve method protocols, reports and SOPs.

• Assist in the preparation for internal/customer/regulatory inspections.

• Ensure a safe working environment within the laboratory.

• Proactively identify and implement lab process improvements, lean initiatives.

• Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.

• Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.

• Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.

• Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.

• May be required to work shift.

Education and Experience

• Requires BS/BA in Life Sciences or related field with 4+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry. Previous supervisory/ leadership experience in a laboratory environment is required.

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