Position Summary

Manage the QC analysts to ensure data integrity in the QC laboratory. Oversee and maintain QC equipment, including qualification activities. Review Certificate of Compliance (COC) test items and associated data

Responsibilities

• Conduct environmental monitoring and reporting (viable and non-viable particles in air, contact plates, swabs, purified water monitoring).
• Handle and maintain laboratory equipment (e.g., biosafety cabinets, incubators, non-viable particle counters, TOC analyzers, endotoxin testers, conductivity meters), including equipment qualification.
• Perform QC testing of laboratory supplies (e.g., bacterial growth tests, oxidase tests).
• Prepare media for microbial challenge tests.
• Collect and report QC data accurately and timely.

Qualifications

Qualifications

• Lead and manage the Quality Control function within the Bioscience team to ensure timely and accurate testing of raw materials, in-process samples, and finished products.
• Develop, implement, and maintain QC procedures and protocols compliant with GMP and regulatory requirements.
• Oversee method validation, equipment calibration, and maintenance activities in QC.
• Ensure data integrity and adherence to ALCOA+ principles in all QC activities.
• Analyze QC data to identify trends and implement corrective actions.
• Collaborate with manufacturing, R&D, and QA departments to support product quality and process improvements.
• Bachelor’s degree in Chemistry, Biotechnology, or related field.
• Minimum of 10 years of experience in QC roles within GMP-regulated pharmaceutical or biopharmaceutical industries.
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