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.

Qualifications :

• 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.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time