1. Position
- Bioscience QC Leader (Korea Filtration Division)
2. 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.
3. Essential Functions
- 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.
4.
Job Requirements
- 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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