Chemist, QC Specialist

16 hours ago

Richmond Hill, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations. Our focus is on developing and selling generic, biosimilar, and specialty products through vertical integration.

Job Summary

As a Chemist, QC Specialist, you will be responsible for generating results while adhering to Good Manufacturing Practices (GMP) requirements. Your key responsibilities will include analyzing laboratory samples using various chemical and instrumental techniques, in accordance with established compendial and in-house testing methods, under minimal supervision.

Key Responsibilities

  • Perform analysis of all laboratory samples, including raw materials, in-process, finished products, purified water, cleaning validation, and stability samples, using analytical instruments and established analytical procedures and techniques.
  • Notify your supervisor promptly of any observations or results that may affect the validity of data and/or reflect variability in the manufacturing process, where applicable.
  • Document and compile all observations and data obtained from testing, as per established Standard Operating Procedures (SOPs) and good documentation practices.
  • Recognize Out-of-Specification (OOS) or out-of-trend results and, under the direction of the supervisor, assist in the completion of lab investigations.
  • Perform calibration of laboratory equipment as required by the department's established calibration program and GMP requirements.
  • Dispose of waste solvent and order chemicals or laboratory supplies as needed.
  • Work as a member of a team to achieve all outcomes.
  • Work in a safe manner, collaborating as a team member to achieve all outcomes.
  • Demonstrate behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • Perform all other relevant duties as assigned.

Requirements

  • Education: Bachelor's 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 of relevant experience in the analysis of pharmaceutical products.

Knowledge, Skills, and Abilities

  • Knowledge of Excel, Word, and other Microsoft programs and/or laboratory software packages is an asset.
  • Excellent verbal and written English communication skills.
  • Knowledge of GMP/GLP.
  • Problem-solving ability.
  • Proven organization and time management skills, as demonstrated through previous work and/or educational experience.

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