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Job Description
Essential Duties and Responsibilities
- Conduct testing of finished products according to respective test procedures and compendia methods.
- Develop / support method transfers, protocols and validations.
- Develop equipment qualification / re-qualification and execute / review protocol.
- Assist Associate Manager in resource allocation, e.g. overtime planning, reagent and consumable inventory management.
- Train junior lab analyst on the testing according to respective test procedures and compendia methods.
- Assist in, or conduct, investigations of lab tests (OOS, LIR, deviations, trend review).
- Maintenance, calibration and basic troubleshooting of laboratory equipment.
- Maintenance of media, buffers and consumable inventory.
- Ensure proper storage and disposal of all chemicals used in the lab.
- Proper documentation, data entry and review of all test results.
- Ensure all quality documents are properly filed and maintained according to SOPs.
- Report all non-conformance and equipment failures to Associate Manager.
- Champion the team in routine housekeeping and continuous improvements in designated labs.
- Ensure compliance to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
- Follow laboratory safety rules, regulations and standard operating procedures required for the task assigned.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
- Other duties as assigned.
