Quality Control Chemist

Job Titles

  • QC Analyst
  • QC Chemist
  • QC Lab Technician
  • QC Technologies

Educational Background

  • B.Sc.
  • College diploma in analytical lab related (entry level)

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

Competitive Advantage

B.Sc. with a course taken on ‘HPLC with hand on experience’ and a course/webinar taken on ‘GMP’

Any transferable skills that speak for your ability to follow instructions and written procedures without any deviation

Job Search Tips

If all the QC chemist/ analyst positions ask for experience, apply for a lab assistant or lab technician position to gain some industry experience. While at this job, keep applying to QC chemist/ analyst positions.

College grads, if you are not able to land a QC chemist/ analyst position, you might want to apply to the most entry level job in the lab such as lab assistant or lab technician and then get promoted. Most of the times, you will need B.Sc. to grow your career further from analyst/ chemist

Manufacturing operator or packaging operator positions are fairly easier to get in and will give you the chance to work in a GMP environment and get your foot in the door. Once at this position, apply for QC analyst/ chemist position. If you still couldn’t get the QC position after one year, you will need a new game plan.

Career Growth

Technician/ Technologist –> Analyst/ Chemist –> Senior –> Group leader –> Supervisor –> Manager –> Director

Other options:

–>transfer to QA department to various roles

–>get promoted to specialized job titles within the QC department

–> if you have certification on project management and preferably PM certified, consider becoming a Project Manager

–> with business certification, you could even transfer to business side of the pharma

–>apply to the country’s regulatory agency labs for a chemist/ analyst position. Example, Health Canada.

  • –>If Canadian citizen and interested in a government job, try
    • Health Canada for Analyst/ Chemist position
    • Environment Canada for Analyst/ Chemist (you will work with environmental samples, not pharmaceutical)
    • Ontario Power Generation as Chemical Technician (Environmental sampling and analysis)
    • Either subscribe to their email job alert or keep checking their website for an opening and apply as soon as possible. The hiring process will take at least a year.

Recommended Readings

  1. Facts About the Current Good Manufacturing Practices (CGMPs)
  2. USP <1029> Good Documentation Guidelines
  3. USP <621> Chromatography
  4. USP <1224> Transfer of Analytical Procedures, USP <1225> Verification of Compendial Procedures