Technician, QC Pack Comp QS4-GQC-RMTS R

Job Summary

Responsible for generating accurate results while following cGMP requirements.  Responsible for analyzing Packaging Material in accordance with established compendia and in-house testing methods and approved specifications, while under minimum supervision.

Job Responsibilities

• Receives and tests incoming printed, unprinted components to ensure conformance with specifications.
• Identifies and reports any Out-of-Specification (OOS) /Out-of-Trend or Questionable results, or any issues of non-conformance to Supervisor immediately. Under the direction of the Supervisor assists in the completion of lab investigations.
• Performs Daily calibration of lab equipment such as balance, pH meter and Milli-Q Water in accordance with established procedures.
• Performs calibration / verification of all applicable test equipment according to the established procedures.
• Performs all work in accordance with all established regulatory, compliance and safety requirements.
• Maintains compliance to all health and safety standards, Current Good Manufacturing Practices, Current Good Laboratory Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex’s Health and Safety policies, and Safe Work Procedures (SWPs).
• Maintains Packaging Component Standards in compliance established procedures as required.
• Prepares and maintains inventory of testing materials.
• Works as an effective team member to meet departmental goals and initiatives, sharing knowledge with team members and others as required.
• 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

• Education
  • Bachelor of Science from a recognized educational institution in Chemistry or a related field;
  • OR
  • Community College diploma in a related field and a minimum of 1 year relevant experience in the analysis of pharmaceutical products.

• Knowledge, Skills and Abilities
  • Good English communication skills both written and oral.
  • Good interpersonal skills.
  • Detailed oriented with good analytical skills.
  • Good understanding of cGMPs and cGLPs.
  • Knowledge of MS Office software including Word, Excel and Access.
  • Strong organization and time management skills as demonstrated through previous work and/or educational experience

• Technology/Instrumentation (Type & Complexity)
  • UV, FT-IR, TOC analyser, DSC, TVS, Torqmeter, Conductivity,
  • Performs Daily calibration of lab equipment such as balance, pH meter and Milli-Q Water in accordance with established procedures.

• Experience
  • Community College diploma combined with minimum of 1 year relevant experience in the analysis of pharmaceutical products.
  • 1-2 years of experience in printed components testing would be an asset