Associate Quality Control

7 days ago

Tuas, Singapore Amgen Full time

Career Category

Quality

**Job Description**:
Role Description:

- Execute routine microbial methods and testing in a GMP biopharmaceutical environment, including but not limited to bioburden, microbial limits, endotoxin, growth promotion, PCR, microbial identification and biological indicator testing, for samples which include but are not limited to raw materials, environmental monitoring, GMP utilities, in-process and final drug substance, validation samples.
- Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples, as well as supporting shipment of samples to Amgen network sites and contract labs.
- Support routine activities over the weekends and public holidays as scheduled.
- Troubleshoot problems and conduct investigations. Own Class 1 and Class 2 non-conformances, CAPAs and effectiveness verifications. Participate in cross functional investigations.
- Plan and execute equipment installation, commissioning and qualification, reagent and sample qualification. Participate and support plant validation activities.
- Plan and execute method transfers, method verification/qualification/validation and contract lab qualification
- Plan and execute microbiology-related studies.
- Author, revise and review documents and reports including but not limited to SOPs, JHA, METs, trend reports, qualification/validation summary reports, technical reports, method assessments, technical assessments, microorganism assessments.
- Prepare QC metrics including but not limited to bioburden excursion, microbial recovery rate, EM excursion rate
- Review of compendial and operating standard changes and perform/participate in gap assessments.
- Perform risk assessments and participant in cross functional risk assessments.
- Participate and represent ASM in network meetings if required.

Education / Licenses
- Degree in Microbiology, Biology or related technological field.

Relevant Experience
- 4-6 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry.

Competencies / Skills
- Knowledge and experience in GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods including aseptic laboratory techniques and monitoring of ISO Classified areas
- Experience with Quality Control testing and laboratory operations for common microbiological testing methods and equipment; particularly focused on bioburden, endotoxin, environmental monitoring, viable sample plates’ interpretation.
- Responsibilities will include data analysis and communication of results, writing protocols and performing assay transfer/validation and equipment qualification/verification as well as maintaining and operating specialized equipment.
- GMP laboratory operation including conducting sample management and data management, Part 11 compliance
- Good communication skills (technical writing and verbal communication/presentation)
- Interact effectively and ability to work well in teams
- Ability to manage multiple simultaneous activities in a rapidly changing environment

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