Analyst, Quality Control

Job purpose

The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for analyzing laboratory samples using various chemical and instrumental techniques, in accordance with established compendial and in-house testing methods, while under minimum supervision.

Duties and 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
• Recognizes OOS or out of trend results and under the direction of the Supervisor assists in the completion of lab investigations
• 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 (participate or lead) 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
• Disposes of waste solvents and orders any chemicals or laboratory supplies as required
• Flexibility to shift start time and occasional overtime
• Other duties as assigned

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• 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. Mixture of standing and walking, some light lifting and/or moving of instruments with the aid of a cart.

Physical requirements

Mixture of standing and walking, some light lifting and/or moving of instruments with the aid of a cart.

Direct reports

NA