Quality Control Chemist

4 weeks ago

Richmond Hill, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a Canadian-based global health organization dedicated to producing high-quality, affordable medications for patients worldwide. With a workforce of nearly 7,200 individuals engaged in manufacturing, research and development, and commercial operations, Apotex ensures that its medicines are accessible in over 75 countries globally. The company focuses on the development and marketing of generic, biosimilar, and specialty products through vertical integration.
For further details, please visit our website.

Position Overview

The successful candidate will be accountable for delivering precise results while adhering to current Good Manufacturing Practices (cGMP). This role involves the analysis of packaging materials, dosage forms, raw materials, and process validation samples using various chemical and instrumental methodologies, in line with established compendia and internal testing protocols, while working under minimal supervision.

Work Schedule

Standard working hours are from 8 AM to 4 PM, Wednesday through Sunday.

Contract Duration

This is a one-year contract position.

Key Responsibilities

  • Conduct analyses of packaging materials, labeling, raw materials, in-process samples, dosage forms, purified water, and validation samples utilizing analytical instruments and established procedures.
  • Compile and summarize all data obtained from testing and observations, ensuring compliance with established Standard Operating Procedures (SOPs). Maintain thorough and accurate records of all analyses performed.
  • Identify and report any Out-of-Specification (OOS) or Out-of-Trend results, as well as any non-conformance issues, to the Supervisor promptly. Assist in lab investigations under the Supervisor's guidance.
  • Perform daily calibration of laboratory equipment, including balances, pH meters, and Milli-Q water systems, following established protocols.
  • Collaborate effectively with team members to achieve departmental objectives, sharing knowledge and expertise across the Quality Control (QC) team.
  • Ensure compliance with all health and safety standards, cGMP, current Good Laboratory Practices (cGLP), and regulatory requirements. Uphold responsibilities related to the Ontario Occupational Health and Safety Act and Apotex's Health and Safety policies.
  • Provide technical support or training to team members as necessary.
  • Conduct all work in accordance with established regulatory, compliance, and safety requirements.
  • Manage the disposal of waste solvents and order necessary chemicals or laboratory supplies as needed.
  • Chemists may receive training to work in cross-functional areas within QC as required.
  • Maintain a safe working environment, collaborating as a team member to achieve all objectives.
  • Exhibit behaviors that reflect our organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal compliance with all programs, including the Global Business Ethics and Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.
  • Perform any other relevant duties as assigned.

Qualifications

  • Education: A Bachelor of Science degree from a recognized institution in Chemistry or a related field; or a Community College diploma in a relevant area.
  • Knowledge, Skills, and Abilities: Proficiency in Microsoft Office applications (Excel, Word). Strong theoretical understanding of FT-IR, titration, UV spectroscopy, and chromatography (TLC and column). Excellent verbal and written communication skills in English. Familiarity with cGMP/cGLP. Strong problem-solving capabilities. Proven organizational and time management skills demonstrated through previous work or educational experiences.
  • Technology/Instrumentation: Experience with UV, FT-IR, Karl Fischer Water Tester, pH meter, TOC analyzer, HPLC, UV, dissolution testing, titration, fluorimetric analysis, column chromatography, auto-titrator, viscometer, TLC, melting point determination, osmolality, particulate matter analysis, density measurement, seal integrity testing, and particle size laser analysis.
  • Experience: A minimum of one year of relevant experience in the analysis of pharmaceutical products.

At Apotex, we are dedicated to fostering an inclusive and accessible work environment where all employees feel valued, respected, and supported.

Apotex provides accommodations for applicants with disabilities as part of its recruitment process. If you are contacted to arrange an interview or testing, please inform us if you require any accommodations.

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