Quality Control Analyst
5 days ago
About the Role
The Quality Control Analyst will play a critical role in ensuring the quality and integrity of our pharmaceutical products. This position is responsible for analyzing laboratory samples using various chemical and instrumental techniques, in accordance with established compendial and in-house testing methods.
Key Responsibilities
- Testing of in-process, bulk, finished product, stability samples and raw materials by TLC, UV, IR, HPLC and GC and wet chemistry techniques as per SOP.
- Document test results as per SOP and GMP.
- Recognize OOS or out of trend results and assist in the completion of lab investigations under the direction of the Supervisor.
- Interpret data, communicate results and complete written reports.
- Complete all GMP documentation correctly and in a timely manner.
- Complete all training assignments and maintain personal training records.
- Conduct routine laboratory and Non-Conformance Investigations.
- Initiate and follow through with actions required to close Change Controls.
- Evaluate methods and procedures and suggest improvements and changes as required.
- Dispose of waste solvents and order any chemicals or laboratory supplies as required.
- Flexibility to shift start time and occasional overtime.
Requirements
- Ability to apply knowledge of chemistry, math, instrumentation and statistics to complete tasks.
- Proficiency in various techniques and operation of instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV IR spectrophotometer, Chromatography instruments).
- Ability to work effectively in a team-based environment.
- Proficiency with applicable software (LIMs and Empower).
- Strong organizational, analytical and multi-tasking ability.
- Ability to troubleshoot and resolve issues.
- Excellent written and oral communication skills, particularly with analytical records, reports and investigations.
- Understanding of GMP's.
- B. Sc. or equivalent.
- Minimum 1 - 3 years experience in Pharmaceutical Laboratory environment preferred.
Working Conditions
Generally, fairly pleasant surroundings. Occasional exposure to higher than normal noise levels, frequent exposure to various chemicals used in the testing of raw materials, components and finished products. Occasional exposure to unpleasant odors resulting from testing procedures. Fairly level temperatures.
Physical Requirements
Mixture of standing and walking, some light lifting and/or moving of instruments with the aid of a cart.
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