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Job Titles
- QC Analyst
- QC Chemist
- QC Lab Technician
- QC Technologies
Educational Background
- B.Sc.
- College diploma in Chemical Technology or analytical lab related
Job Functions
- There are 3 main responsibilities
- Routine testing
- Other tests
- Other duties
Routine Testing
- Routine testing is the main duty of a QC analyst.
- The testing could be physical, wet chemistry or instrumentation (HPLC/ GC etc) (e.g. Assay testing, ID testing, pH, viscosity,
- Testing to be conducted as per the approved test method with no deviation. Standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) guidelines should also be followed without any deviation.
- Any deviation or any mistake will require writing Laboratory Investigation Report (LIR) involving the supervisor and the QA department.
- Testing of pharmaceutical dosage forms and raw materials
- In-Vitro performance testing such as dissolution testing for tablets.
- Preparation of solutions, reagents, samples
- Maintain a legible and accurate recording of everything performed in the lab following GMP and Good Documentation Practices (GDP)
- Note: GMP is used by Health Canada. Current Good Documentation Practices (CGMP) is used by FDA
Other tests
- Method Transfer and Method Verification (this is usually done by someone at senior level)
- Standard qualification
- Testing to be conducted as per the approved test method and the protocol with no deviation. Standard operating procedures (SOPs) and GMP guidelines should also be followed without any deviation.
- Any deviation or any mistake will require writing Laboratory Investigation Report (LIR) involving the supervisor and the QA department.
Other duties
- Peer review of lab notebooks
- Daily verification of equipment (e.g. pH meter, balances)
- Calibration of analytical instruments (this is usually done by someone at senior level)
- Ordering and receiving chemicals and lab supplies as needed.
- Maintaining of the lab and the instruments
Must Have Skills
- Knowledge of:
- basic chemistry (e.g. pH, pKa, chemical bonds, acid/base, UV/Vis, density/ specific gravity, moles/ molarity/ molality)
- High Performance Liquid Chromatography (HPLC) and how it is used to analyze samples quantitatively and qualitatively.
- Good Manufacturing Practices (GMP), GDP (Good Documentation Practices as per GMP), WHIMS, Standard Operating Procedures (SOPs), Test Methods
- USP, FDA, Health Canada
- Good documentation practices
- Work well under pressure and in a ‘fast paced and minimal tolerance for mistakes’ environment
- Able to do the same testing over and over again but with different samples.
- Detail oriented and ability to follow written procedures without any deviation
- Honest and transparent
- Able to take responsibility for your own action
- Work well individually and as part of a team
- Professional, fast learner and takes initiative.
- Able to work in a highly regulated environment and follow company Standard Operating Procedures (SOPs), regulatory guidelines and safety standards.
Type of companies that hire
- Pharmaceutical/ Biopharmaceutical/ Radiopharmaceutical
- Regulatory Agencies (Health Canada, FDA)
- Biotech
- Contract Labs
- Cannabis Industry
- Cosmetic companies
- other