Microbiologist II

Purpose: The primary role is to ensure smooth QC operational activities support to routine or new product introduction per cGMP/EHS/Regulatory expectations with global/site standards. Enables QC functional operational readiness, infrastructure/instrumentation support and compliance readiness.
Major Responsibilities:
Team Support
Responsible for supporting QC micro-operations by timely conduct of test/release of routine or new product introduction activities.
Develops technical competency and jointly creates a great place to work in.
Financial Support
Supports financial spending are within the latest best estimates.
Compliance (Quality and Safety)
SME for QC Micro - Operational readiness (Eg: Environment, Utilities and Product test), infrastructure/instrumentation needs and compliance readiness (Eg: Track & Trend) against cGMP/EHS/Regulatory compliance expectations to global/site procedures.
Authors/Reviews lab documentation per cGMP or EHS expectations of the global/local site procedural needs.
Support in resolution of manufacturing/laboratories investigation or exceptions for timely closure or issue resolution.
Support in internal/external audits and enables audit response for a successful outcome in sustaining licenses to operate.
Infrastructure & Instrumentation
Supports QC function infrastructure/instrumentation needs through supporting PM/CAL or Technological refresh needs.
New Product Introduction, Projects & Continuous Improvement
Support in New Product Introduction (Small molecule or Biologic product) are conducted (TMT, Eqmt qualification) and delivered to enable a successful / timely program launch.
Any other task/projects assigned by line manager.
Bachelors in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
Analytical thinking with problem-solving skills and technical writing skills.
Independent and motivated.
Good GMP knowledge/Experience in laboratory
Good Collaborator with cross functional teams.
Able to work towards timeline.
Minimum 4 years for Bachelor graduate with relevant work experience in Biotechnology / Pharmaceutical industry is preferred.

Employment type
Full-time

Work arrangement
No