Quality Control Chemist

There are 3 main responsibilities
1. Routine testing
2. Other tests
3. Other duties

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

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.

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

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.