Perform routine and non-routine analytical testing of pharmaceutical drug substances and drug products using techniques such as titrations, stability-indicating HPLC analysis, pH analysis, viscosity assessment, and visual inspection.
Perform testing on samples promptly, ensuring adherence to assigned testing deadlines.
Communicate with the manager regarding any challenges in meeting scheduled testing timelines.
Promptly notify management of unexpected test outcomes.
Document results in a standardized format and record them accurately and on time.
Contribute to the integration of new testing techniques into the lab.
Support development of new laboratory methods in response to client or market needs.
Stay current with industry technology and instruments, with a focus on HPLC analytical chemistry applications in pharmaceuticals.
Assist in R&D and stability testing, including preparing samples, writing protocols, establishing specifications, performing testing, entering data, and writing reports.
Use statistical methods to interpret results using Excel or other statistical software.
Support other laboratory departments such as microbiology, sterility or molecular biology as needed.
This may include but is not limited to environmental monitoring, assisting sterility tests, daily lab upkeep, equipment management, inventory management, plate incubation and enumeration, and documentation.
Support and collaborate with the Quality Assurance department to address quality incidents such as OOS results and deviations by participating in initial investigations.
Assist the Quality Assurance team in identifying impacts, root causes, and CAPAs to ensure regulatory compliance.
Aid in developing Corrective and Preventive Action (CAPA) plans, ensuring timely implementation.
Participate in the creation and execution of Change Control documentation.
Write, revise, and review methods, work instructions, reports, and SOPs as required.
Adhere to company policies and all applicable SOPs.
Perform all work in compliance with ISO 17025, Controlled Substance regulations, ISO 9001, cGMP, cGLP, A2LA, WHMIS, USP, ICH, and regulatory requirements.
Adhere to good documentation practices and data integrity principles (GDP, ALCOA+, data integrity for computerized systems) and laboratory best practices.
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Follow all safety, environmental, and waste disposal procedures.
Support internal audits, client audits, and regulatory inspections as needed.
Maintain a clean, orderly, and safe laboratory workspace and adhere to all health and safety protocols.
Strong knowledge of pharmaceutical analytical chemistry and quality control principles.
Strong understanding of ISO 9001 standards and quality management principles.
Strong understanding of ISO 17025 standards for testing and calibration laboratories.
In-depth knowledge of Health Canada and GMP regulations.
Experience with sample preparation chemistry and wet chemistry analysis.
Proficiency in Stability-Indicating HPLC method development and validation, including HPLC troubleshooting and maintenance.
Competence in laboratory-related computer applications and programs.
Excellent analytical, decision-making, and interpersonal skills.
Strong verbal and written communication abilities.
Problem-solving skills for routine and complex laboratory issues.
Physical dexterity for accurate and precise testing.
Ability to read, understand, and comply with company policies, SOPs, and safety regulations.
Intermediate skills in Microsoft Office (Word, Excel, Outlook, and PowerPoint).
A post-secondary education in Chemistry is required; a university degree is preferred. However, a college diploma in a science-related field (minimum two-year program) is also acceptable.
Minimum of two years’ experience in an analytical laboratory or a related field (Wet Chemistry, Gas Chromatography, Liquid Chromatography, Mass Spectrometry, ICP/ICP-MS, Microbiology).
Experience in microbiology and/or pharmaceutical industry is a plus.
Ability to carry laboratory equipment, reagents, and samples.
Fine motor skills and manual dexterity for tasks such as pipetting, handling small samples, and operating laboratory equipment.
Comfort with wearing PPE, including lab coats, gloves, safety glasses, and respirators when necessary.
Safe handling of chemicals and adherence to all safety protocols.
Willingness to work with hazardous chemicals (NIOSH).
Capability to work in a Biological Safety Cabinet and or Containment Ventilation Enclosure.
Flexibility to modify work hours to support the facility after hours or on weekends, as needed and where appropriate notice has been given.
Application and Questionnaire - Candidates submit an application and complete the initial questionnaire.
Pre-Screen Video Interview - Qualified candidates will be invited within one week to complete a short one-way video pre-screen.
In-Person Interview - Shortlisted candidates will be invited to attend an in-person interview at our head office.
Offer and Background Check - The successful candidate will be offered the position, pending a criminal background check and references.
Canadian private healthcare company supporting patients, physicians, and manufacturers with specialty pharmaceuticals, patient programs, and care logistics.
