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Senior Quality Control Specialist

2 months ago

Mississauga, Ontario, Canada Resilience Full time
Job Summary:

The Senior Quality Control Specialist will be responsible for ensuring the quality of in-process materials, validation, stability, and final products for biochemical assessment according to cGMP and company specifications. This role will involve reviewing, troubleshooting, instrument maintenance, writing protocols/reports, and cross-training of other QC Chemistry analysts.

Key Responsibilities:
  • Perform sample analysis using bioanalytical test methods such as HPLC, UPLC, BCA, SDS-PAGE, ELISA, Western blot, and UV-Vis, as per SOPs and/or protocols.
  • Perform routine maintenance on laboratory instruments.
  • Follow established procedures for chemical receipt, inventory, use, and discard.
  • Troubleshoot methods and equipment as required.
  • Author SOP and QCP methods, and manage through change control.
  • Lead and execute instrument qualification work as required.
  • Review test worksheets, including raw data and audit trails.
  • Develop and execute QC studies and write reports.
  • Participate in scheduled cleaning and other laboratory housekeeping duties.
  • Employ good documentation practices when generating raw data, reports, SOPs, and other documentation.
  • Author lab investigations with supervisor when required.
  • Report to supervisor any deviations from company procedures or other discrepancies that may affect product quality or cGMP status according to established procedures.
  • Perform other routine testing and training to support analytical testing requirements in the lab.
  • Ensure documentation is accurate and up-to-date.
  • Once qualified as a trainer, perform cross-training of other QC analysts.
  • Identify and lead corrective action plans, participate in identifying root causes, and communicate with other departments regarding pending issues.
Requirements:
  • Strong understanding of GMP and GLP.
  • Advanced knowledge and practical experience in protein analysis, such as BCA, Western blot, SDS-PAGE, ELISA, concentration analysis using UV-Vis Spectrophotometer, HPLC/UPLC.
  • Data analysis, statistics, and report preparation with knowledge of MS Word, Excel, and Outlook.
  • Advanced knowledge of compendial test requirements, US and Europe Pharmacopeia.
  • Strong attention to detail, self-motivated, highly organized, and able to work in a fast-paced laboratory environment.
  • Able to multi-task.
  • Ability to learn new bioanalytical techniques quickly.
  • Good verbal and written communication (technical writing/protocols/reports).
  • Strong presentation skills.
Preferred Qualifications:
  • Bachelor's degree in Biochemistry/Chemistry, or Chemical Engineering, or College Diploma in Biotechnology, Chemical Engineering Technology, or Chemical Laboratory Technology, with at least 3-5 years related experience in a quality lab environment (biologics/pharmaceutical preferred) or Master's degree with 2-3 years' related experience.
  • Working experience with HPLC will be an added advantage.
Additional Requirements:
  • Pre-employment medical and medical re-examination; inclusive of eye examination and color blindness test, performed every 2 years or as per Resilience's SOPs.
  • This position requires vaccination for Hepatitis A and B.
  • Job requires shift work, weekends, and occasional extended shifts and possible short notice schedule shift changes.