QC Microbiologist

Bora Pharmaceuticals•Mississauga, ON

6d•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. This is a permanent fulltime position. This job posting reflects a current vacancy within the organization. The position is active, approved, and intended to be filled as part of our staffing needs. This posting is for an existing and currently open position.

Requirements

Minimum of 2 years of Quality Control microbiology experience in pharmaceutical laboratory environment.
Good theoretical and practical knowledge of microbiological techniques.
Knowledge of Microbial IDs and investigations.
Demonstrated computer proficiency in LIMS, SAP and Excel.
Good knowledge of laboratory GMP and the Pharmacopoeias.
Good verbal and written communication skills.
Works well in a fast-paced team environment and individually.
Ability to manage multiple projects and tasks concurrently and effectively.

Nice To Haves

University degree in Microbiology.

Responsibilities

Perform microbiological analyses on raw materials, finished products and environmental monitoring samples.
Perform microbial method validation of raw materials and finished products within defined project timelines. This includes writing of test protocols and reports, setting up tests, transfers and reading plates using aseptic technique.
Maintain QC laboratory equipment performance: Perform assigned laboratory duties; maintain equipment according to SOPs & manufacturers’ guidelines.
Maintain quality results: Perform tests according to quality & customer service standards; document results according to cGMP standards; assist in investigations of OOS results by problem solving & troubleshooting; write minor deviations; ensure compliance to cGMP; write investigation reports; assist in regulatory & corporate audits; conduct & participate in self-inspections.
Complete operational requirements as per schedule: Attend daily meetings; support process validation; implement efficiencies to improve productivity; review QC procedures; implement new procedures; maintain QC laboratory supplies inventory.
Implement new programs, tests methods, instrumentation, & procedures: Prepare proposals; initiate change proposals; write justifications & feasibility reports; perform parallel testing; evaluate new methods.
Maintain a safe & healthy work environment: Follow all safety policies; maintain a clean & orderly work area; report any potentially unsafe conditions within the workplace.
Perform all work according to cGMP and following regulatory and Bora's standards, including thorough documentation and prompt reporting of any anomalies.
Maintain laboratory systems and participate in projects as required.
Working closely with others in the group to achieve business objectives.