Scientist II - QC Microbiology

Roles & Responsibilities

Responsibilities:

· To perform quality control microbiological testing of raw materials, incoming goods, intermediates, in-process, drug substance, and/or finished products under cGMP conditions for QC release or part of stability studies

· To perform monitoring and testing for the facility and utilities system

· To support instrument qualification

· To support equipment qualification e.g., controlled temperature units, isolator, biosafety cabinets

· To perform and coordinate calibration, preventative maintenance and repairs or laboratory instruments/equipment

· To support aseptic process simulations

· To support microbiological method transfer/development/validation/verification/suitability

· To perform periodic review for laboratory documents

· To manage microbiological inventory required for sampling and testing

· To ensure adherence to ALCOA principles for managing laboratory data

· To adhere to site/job role training plan, and maintain individual training records

· To support continuous improvement initiatives

· To maintain laboratory housekeeping using 5S approach

· Ensure timely escalation of investigations accidents, near misses and breaches of policies

To carry out tasks required by the reporting Manager

Education background:

Bachelor Degree in Microbiology, Biology, Biotechnology, Life Sciences or equivalent.

Experience:

2-3 years of experience in the pharmaceutical or medical devices industry, with experience on working in a laboratory environment preferred, but fresh graduates with laboratory experience during tertiary studies is acceptable.

Tell employers what skills you have

CGMP manufacturing
Biosafety
Process Research
monitoring of equipment
Microbiology
Temperature Controlled
Stability
Chemistry
Equipment Qualification
Molecular Biology
Prescription Drugs
Receiving Goods
Microbiological Testing
Laboratory
Product Launch