Quality Control Chemist

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
    1. Routine testing
    2. Other tests
    3. 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

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