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Quality Control Laboratory Analyst

2 months ago

Concord, Canada AX Pharmaceutical Corp Full time

Company: AX Pharmaceutical Corp

Position: Quality Control Laboratory Analyst

Location: 100 Tesma Way, Unit 8, Concord, Ontario, Canada, L4K 0J9

Department: Quality and Compliance Department

Responsible to: Quality Control Manager


Position Summary: The quality control laboratory analyst’s primary responsibility is testing materials submitted to the Quality Control lab for batch release or stability according to company procedure as well as appropriate pharmacopeia, regulatory and quality standards meeting Health Canada and US FDA regulations, as well as USP and/or EP pharmacopeia standards. The analyst is responsible for all aspects of testing including control of materials, handling of materials, conducting, analyzing and reporting test results, stability study monitoring, etc. The analyst is further responsible for maintain laboratory operations and good laboratory practices (safety inspections, equipment cleaning and maintenance, etc.). This function maintains quality compliance with Current Good Manufacturing Practice (cGMP), current Good Documentation Practices (GDP) and AX standard operating procedures (SOPs).


General Responsibilities:

- Execute assigned testing according to validated analytical methods and company standard operating procedures.

- Document all activities in real time in analyst notebook.

- Analyze raw data and report test results as per company reporting procedures and in accordance with applicable regulatory and pharmacopeial requirements.

- Reporting of test results and preparation of analytical data reports according to company procedures and all applicable regulatory/pharmacopeial requirements.

- Maintain proper storage and handling of samples, standards, reagents and materials in the lab.

- Complete change controls and deviations where required according to AX standard operating procedure.

- Operation of laboratory instrumentation including HPLC, GC, FTIR, UV-VIS Spectrophotometer, Karl Fischer Titrator, Microbalance, Melting Point apparatus, etc.

- Conduct daily/weekly/monthly calibration of PQ checks of instruments as required.

- Review qualification/calibration/preventative maintenance documentation from third party vendors.

- Assist with method validation/verification activities by conducting analysis according to written and pre-approved validation/verification protocols.

- Ensuring that all official company documentation is completed according to Good Documentation Practices and AX standard operating procedure.

- Familiarity and adherence to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and applicable regulatory guidelines from Health Canada and FDA.

- Maintain a safe and clean working environment.

- Frequent intra-department and inter-departmental coordination with Quality Assurance, Production, and Quality Control teams.

- Performing all work in accordance with all established regulatory, compliance and safety requirements, and AX standard operating procedures

- The successful candidate is highly motivated and efficient, capable of working in a fast-paced environment and effectively meeting deadlines.


Working Conditions and Environment:

- normal business environment

- business casual attire

- working hours 9:00am - 5:00pm Monday to Friday


Skills and Qualifications: Bachelor’s Degree in Biology, Biochemistry, Chemistry, or similar Life Science Minimum of 3 years working experience in a lab environment. Previous experience in a GMP environment preferred. Experience interpreting regulatory and guidance documents such as USP, FDA, Health Canada, and ICH. Ability to read, analyze and interpret scientific and technical reports, common pharmaceutical tests for Active Pharmaceutical Ingredients (APIs), procedures, operating instructions, and/or scientific publications (assay, impurities testing, residual solvents, etc.). Familiarity with the principles of testing and dedicated equipment at AX Pharmaceutical (HPLC, GC, FTIR, UV-VIS Spectrophotometry, Karl Fischer Titration). Superior organizational and interpersonal skills. Ability to manage multiple projects and tasks concurrently and effectively. Excellent written and oral communication skills is a must. Computer proficiency with MS Office programs. Familiarity with Agilent CDS, Agilent Microlab, and/or Mettler-Toledo LabX software is a plus. Ability to meet deadlines and prioritize tasks with strong attention to detail. Behaviors aligned with AX Pharmaceutical Corp principles and values.