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Quality Assurance Specialist
3 months ago
The Quality Assurance Specialist performs essential chemical and physical evaluations in the laboratory, adhering to the established schedule while following specifications, methodologies, procedures, and Good Manufacturing Practices (GMP).
Position Details:
Shift: 12-hour weekend schedule (Friday, Saturday, and Sunday)
Key Responsibilities:
- Conduct analyses of finished products, bulk materials, raw ingredients, and stability samples in accordance with current methodologies.
- Guarantee the accuracy and quality of data generated within the QC laboratory.
- Monitor and document the calibration and maintenance of all laboratory instruments.
- Maintain comprehensive records of equipment, standards, and manage the inventory of reagents, standards, and consumables.
- Engage in investigations, problem resolution, and contribute to the development of research and development methodologies.
Required Skills and Experience:
- Completion of a College Diploma (DEC) or a Bachelor of Science degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- 3 to 5 years of experience in quality control within the pharmaceutical sector.
- Familiarity with Canadian Good Manufacturing Practices (GMP) as per Health Canada and American regulations (FDA).
- Understanding of laboratory investigation protocols, including FDA guidelines for Out of Specification (OOS) and Out of Trend (OOT) investigations.
- Knowledge of Pharmacopoeias (USP, Ph. Eur., and BP) and their practical applications in a laboratory setting.
- Proficiency in analytical techniques such as HPLC (UPLC) and GC.
- Strong teamwork capabilities.
- Ability to mentor and train new staff members.
Additional Information:
Employment Type: Part-time