Senior Quality Assurance Specialist

6 days ago

Mississauga, Ontario, Canada Resilience Full time

Job Summary:

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Resilience. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our biomanufacturing processes.

Key Responsibilities:

  • Perform sample analysis using advanced bioanalytical techniques such as HPLC, UPLC, PCR, and ELISA, as per SOPs and protocols.
  • Develop and execute QC studies and write comprehensive reports.
  • Lead and execute instrument qualification work as required.
  • Assist in method transfer and qualification activities.
  • Respond to internal and external auditors on questions related to assays and instruments.
  • 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.
  • Report to supervisor any deviations from company procedures or other discrepancies that may affect product quality or cGMP status.
  • Perform other routine testing after training to support analytical testing requirements in the lab.
  • Ensure documentations are accurate and up to date.
  • Assist in implementation of corrective action plans, participate in identifying root causes, and communicate with other departments regarding pending issues.

Requirements:

  • Strong understanding of GMP, GLP, 21 CFR, ICH, Pharmacopeial, and Regulatory guidelines.
  • Advanced knowledge and practical experience in protein analysis, including BCA, Western blot, SDS-PAGE, ELISA, concentration analysis using UV-Vis Spectrophotometer/Nephelometry/Cell culture testing, PCR, HPLC/UPLC.
  • Data analysis, statistics, and report preparation with knowledge of MS Word, Excel, and Outlook.
  • Strong attention to detail, self-motivated, highly organized, and able to work in a fast-paced laboratory environment.
  • Able to multi-task and very flexible based on job priorities.
  • Ability to learn new bioanalytical techniques quickly.
  • Good verbal and written communication (technical writing/protocols/reports).
  • Strong presentation skills.
  • Strong instrument trouble shooting skills.

Preferred Qualifications:

  • Bachelor's degree (Biochemistry/Biotechnology/Chemistry) with 7 years related experience within a quality lab environment (biologics pharmaceutical preferred) or Master's degree (Biochemistry/Biotechnology/Chemistry) with 5 years related experience within a quality lab environment (biologics pharmaceutical preferred).
  • Very good knowledge in HPLC/UPLC/Plate reader/spectrophotometer.
  • Advanced Bioanalytical instruments/HPLC/GC/Imager.

Additional Requirements:

  • Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as required.
  • 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.

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