QC Stability Coordinator Assistant

Bora Pharmaceuticals•Mississauga, ON

6d•CA$46,430 - CA$58,040•Hybrid

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 12-month fixed-term contract (FTC) and a backfill position. The role is an active, approved vacancy within the organization and is intended to support current staffing needs. The General Description is to participate in the organization and maintenance of the stability program. Work to achieve compliance with global regulatory and customer requirements for stability. Ensure samples are set down and pulled from stability chambers within required testing windows and provide written stability reports to customers.

Requirements

1-3 years of pharmaceutical experience with the knowledge of cGMP, ICH and FDA stability guidelines.
Excellent written and oral communication skills.
Extensive computer experience including LIMs software, SAP, Statistical programs, MS Word and Excel.
Experience in the evaluation of analytical data, including statistical interpretation of stability data.
Good overall knowledge of pharmaceutical business operations.
College diploma/certificate in Chemistry.
Computer proficiency for MS Word & MS Excel.
GMP and GLP experience / knowledge.

Nice To Haves

Hands-on lab testing experience is an asset.
Bachelor of Science degree in Chemistry.

Responsibilities

Help to create and maintain stability protocols.
Maintain the stability chamber stability sample inventory and routinely monitor chamber performance.
Ensure remaining samples from completed stability studies are appropriately disposed as per local procedures.
Assist in stability data review and trending of results upon completion of timepoint testing.
Participate in preparation of stability reports according to agreed schedule/due dates for US FDA annual reports, Canadian submission and ROW countries.
Perform stability pulls according to the stability pull-schedule.
Check production schedules for batches to be set down.
Ensure that laboratories aware of incoming stability batches for testing and monitor the execution status.
Labware pull check 3 times every week.
Preparation of sample for stability study.
Stability report data check.