QC Microbiology Associate

Role: QC Microbiology Associate

Location: Cambridge, MA, 02142

Duration: 1 Year (Potential for extension)

This is a first shift position.

100% On- site

Description:

The QC Microbiology associate is responsible for the performance of the cGMP routine/non-routine QC sampling and testing within the function of the QC Microbiology Laboratory supporting our Vaccine manufacturing site.

Key Responsibilities:

Perform routine environmental monitoring of the manufacturing facility.

Perform routine sampling and testing of the utility systems.

Perform Manufacturing Process Monitoring Perform QC sample receipt and aliquoting as necessary.

Complete documentation in accordance with current Good Manufacturing Practices (cGMP) ensuring data integrity.

Support Laboratory investigation, deviation management and CAPA.

Maintain QC Micro related systems to ensure compliance with industry standards supporting internal/external audits.

Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies.

Required Qualifications:

BS in a relevant scientific discipline or 2-5 years Quality Control experience in a cGMP organization with a focus in Microbiology

Knowledge of GMP, microbiology, aseptic technique, and general laboratory instrumentation (preferred)

Experience performing lab investigation, deviation writing, participate in change controls, and CAPAs investigations.

Assist in the generation, review and approval of protocols, reports, and CofA

Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.

Ability to collaborate effectively in a dynamic, cross-functional environment.

Excellent communication skills (verbal and written)

Perform environmental monitoring and utility samples of the facility.

Perform Bioburden and endotoxin testing.

Utilizing different microbiological testing techniques to ensure the safety of the facility environment.

Adhere to environmental monitoring procedures.

Perform plate reads and record results.

Support raw material sampling and testing.

Author and revise standard operating procedures.

Inform supervisor/manager upon observing OOS, or generation of deviations.