Chemist, QC

Job Summary

Responsible for generating 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 working under minimal supervision.  If required, responsible to review documentation for the QC department.

Job Responsibilities

• Performs analysis of all laboratory samples including raw material, in-process, finished products, purified water, cleaning validation, stability samples and analysis associated with method transfer or method verification using analytical instruments and established analytical procedures and techniques.
• Document all observations and data obtained from testing as per established SOPs and Good Documentation Practices.
• Recognizes OOS or OOT results under the direction of the Supervisor
• Performs general maintenance and daily check of laboratory equipment as required

• Troubleshoots instrumentation and method problems with the Supervisor’s assistance

• Disposes waste solvents and orders any chemicals or laboratory supplies as required.

• Performs role of document reviewer as outlined below:
  • Reviews and signs off the completed electronic and/or paper data associated with a specific analysis that they have been trained on .
  • Ensures accurate results that conform to current specifications, according to Good Manufacturing Practices, in house, compendial and regulatory requirements, and verifies all calculations for mathematical and analytical accuracy.

• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned

Job Requirements

• B.Sc. from a recognized educational institution in Chemistry or a related field and a minimum of 1 year relevant experience in a pharmaceutical lab environment;  or Community College diploma in a related field and a minimum of 2 years relevant experience in the analysis of pharmaceutical products.

• Knowledge of Excel, Word and other Microsoft Office Programs and/or laboratory software packages is an asset.

• Sound working and theoretical knowledge of automated laboratory instrumentation such as Dissolution, IR, UV/VIS spectophotometry and Karl Fischer.

• Detail oriented with problem solving and instrument troubleshooting ability.

• Excellent verbal and written English communication skills.

• Excellent interpersonal skills.

• Knowledge of GMP/GLP.

• Proven organization and time management skills as demonstrated through previous work and/or educational experience.