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Quality Control Analyst
3 months ago
Position Overview: The Quality Control Analyst independently conducts chemical and physical evaluations in the laboratory, adhering to established specifications, methodologies, procedures, and Good Manufacturing Practices (GMP).
Shift Details: Weekend 12-hour shift (Friday, Saturday, and Sunday)
Key Responsibilities:
- Perform analyses on finished products, bulk substances, raw materials, and stability samples in accordance with current methodologies.
- Guarantee data integrity and uphold quality standards within the QC laboratory.
- Conduct maintenance and calibration of all laboratory equipment.
- Maintain comprehensive records of equipment, standards, and inventory of reagents, solvents, and consumables.
- Engage actively in investigations, problem-solving initiatives, and continuous improvement efforts.
Qualifications and Skills:
- College or Bachelor’s degree in a scientific discipline (Chemistry, Biochemistry, or a related field).
- 3 to 5 years of experience in quality control within the pharmaceutical sector.
- Familiarity with Canadian (Health Canada) and American (FDA) Good Manufacturing Practices (GMP).
- Understanding of laboratory investigation protocols (FDA guidelines for OOS and OOT investigations, MRHA).
- Knowledge and expertise in pharmacopoeias (USP, Ph. Eur., and BP) and their application in laboratory settings.
- Extensive knowledge of HPLC (UPLC) and GC methodologies.
- Strong teamwork abilities and capacity to mentor new personnel.
Please note that the use of the male gender is for simplification purposes.