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Quality Assurance Specialist
2 months ago
Job Summary
The Quality Control Analyst plays a crucial role in ensuring the integrity and quality of data at the QC laboratory. This position requires a strong understanding of chemical and physical activities, as well as the ability to carry out analyses of finished products, bulks, raw materials, and stability according to established methods and procedures.
Key Responsibilities
- Conduct chemical and physical analyses of finished products, bulks, raw materials, and stability according to established methods and procedures.
- Ensure the integrity and quality of data at the QC laboratory, including tracking interviews or calibrations of all laboratory instruments.
- Maintain equipment records, standards, and reagent, standard, and/or consumables inventory.
- Participate in investigations, problem-solving, and the development of R&D methods.
Requirements
- Diploma of College Studies (DEC) or a Bachelor of Science (Chemistry, Biochemistry, Pharmaceutical program, or a related discipline).
- 3 to 5 years of experience in quality control in the pharmaceutical industry.
- Knowledge of Canadian Good Manufacturing Practices (GMP) (Health Canada) and American (FDA).
- Knowledge of laboratory investigation guides (FDA guidance to OOS and OOT investigations, MRHA).
- Knowledge of Pharmacopoeias (USP, Ph. Eur. and BP) and their applications within a laboratory.
- Knowledge with the following techniques: HPLC (UPLC) and GC.
- Skills for teamwork and ability to train new employees.
Additional Information
This is a part-time position with a 12-hour weekend shift (Friday, Saturday, and Sunday).
