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Quality Control Chemist
3 months ago
About Apotex Inc.
Apotex Inc. is a globally recognized Canadian health organization dedicated to producing high-quality, cost-effective medications for patients worldwide. With a workforce of nearly 7,200 employees across manufacturing, research and development, and commercial operations, Apotex ensures that its medicines are accessible in over 75 countries. The company focuses on the development and distribution of generic, biosimilar, and specialty products through vertical integration.
For further details, please visit our website.
Position Overview
The role involves generating precise analytical results while adhering to current Good Manufacturing Practices (cGMP). The incumbent will be responsible for the examination of packaging materials, dosage forms, raw materials, and process validation samples using a variety of chemical and instrumental methodologies, following established compendia and internal testing protocols, all 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 cleaning validation samples utilizing analytical instruments and established procedures.
- Compile and summarize all data from testing and observations, ensuring compliance with established Standard Operating Procedures (SOPs) while maintaining accurate records of all analyses performed.
- Identify and report any Out-of-Specification (OOS) or questionable results to the Supervisor immediately, assisting in lab investigations as directed.
- Perform daily calibration of laboratory equipment, including balances, pH meters, and Milli-Q water systems, in accordance with 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 regulations, cGMP, and current Good Laboratory Practices (cGLP). Maintain accountability for adherence to the Ontario Occupational Health and Safety Act and Apotex's health and safety policies.
- Provide technical support and training to team members as necessary.
- Conduct all work in compliance with established regulatory, safety, and quality requirements.
- Manage the disposal of waste solvents and the ordering of chemicals or laboratory supplies as needed.
- Chemists may receive training to work in various functional areas within QC as required.
- Work collaboratively in a safe manner to achieve all desired outcomes.
- Exhibit behaviors that reflect our organizational values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal compliance with all relevant programs, including Global Business Ethics, Quality policies, Safety and Environment policies, and HR policies.
- Perform any other relevant duties as assigned.
Qualifications
- Education: A Bachelor of Science degree in Chemistry or a related field from a recognized institution; or a Community College diploma in a related discipline.
- Knowledge, Skills, and Abilities: Proficiency in Microsoft Office Suite (Excel, Word), a solid 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 standards. Strong problem-solving, organizational, and time management skills demonstrated through prior experience.
- Technology/Instrumentation: Experience with UV, FT-IR, Karl Fischer Water Tester, pH meters, TOC analyzers, HPLC, dissolution testing, titration, fluorimetry, column chromatography, auto-titrators, viscometers, TLC, melting point determination, osmolality, particulate matter analysis, density measurements, seal integrity testing, and particle size analysis.
- Experience: A minimum of one year of relevant experience in the analysis of pharmaceutical products.
At Apotex, we are dedicated to creating an inclusive and accessible work environment where all employees feel valued, respected, and supported.
Apotex provides accommodations for applicants with disabilities throughout the recruitment process. If you are contacted for an interview or testing, please inform us if you require any accommodations.
