Analyste en biochimie, Contrôle qualité (Soirs)-Quality Control Analyst I - Biochemistry (Evenings)

• Perform analytical tests on biochemical samples using approved methods.
• Ensure all equipment used in the chemistry lab are calibrated.
• Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
• Monitor and maintain the inventory level of supplies used.
• Perform all lab functions in compliance with cGMP.
• Writing and reviewing SOPs
• Perform chemical and biochemical tests in according with USP, EP and BP
• Perform analytical testing on raw material, plasma-derived products, and utilities as per approved methods, specifications, procedures and GMP.
• Ability to perform biochemical techniques such as electrophoresis, ELISA testing, and nephelometric analysis.
• Perform QC instrument verification and qualification as needed.
• Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.
• Recognize and report aberrant test results and sample conditions. Report any out-of-specification (OOS), out-of-trend (OOT) or atypical results immediately to the QC Manager and participate in laboratory investigations, as required
• Ensure training is current for all job functions performed.
• Order, stock and receive laboratory supplies.
• Complete all required documentation legibly and accurately. Maintain Good Documentation Practices when completing logbooks, analytical work sheets, training records and all other GMP documents. Ensure the integrity and traceability of data generated
• Collaborate with QC Supervisor and Manager to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies.
• Perform additional duties as assigned

Qualifications:

• Minimum of a bachelor’s degree in Biochemistry or related scientific discipline and experience in a Biotech or pharmaceutical QC Laboratory preferred. GMP experience required.
• A working knowledge of the cGMP, QC laboratory environment, and equipment associated with testing of biopharmaceutical products
• Related experience: Minimum of 3 years of working experience in a GMP laboratory role
• Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European market
• Knowledge of cGMPs, good documentation practices and data integrity requirements.
• Experience with LIMS systems preferred.
• Strong computer skills with MS Office (MS Word and Excel).
• Strong organizational skills, including attention to detail and ability to meet deadlines
• Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes.
• Ability to follow written procedures with close attention to detail.
• Must be able to work independently and as part of a team
• Able to multi-task under strict deadlines
• Be proactive and resourceful to help prevent and solve problems
• Excellent oral and written communication skills and good interpersonal skills
• Bilingual in both French and English. English proficiency is required for documentation, reporting, and interactions with Health Canada, the FDA, and other multidisciplinary departments within the company that are based outside Quebec and Canada (such as Spain and the USA).

Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec