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Senior Analyst, Quality Control

2 months ago

Mississauga, Ontario, Canada Resilience Full time

Highly skilled bioanalytical technologist sought to perform complex sample analysis, develop and execute QC studies, and lead instrument qualification work in a fast-paced laboratory environment.

Job Title: Bioanalytical Technologist

About Resilience

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Responsibilities:

  • Perform sample analysis using bioanalytical test methods such as HPLC, UPLC, PCR, PA800, BCA, SDS-PAGE, ELISA, Enzyme activity, Western blot and UV-Vis, as per SOPs and / or protocols
  • SME for the assays performed
  • Involve in method transfer and qualification activities
  • Respond to internal and external auditors on questions on assays and instruments
  • Assist Lab management in internal, client and regulatory audits
  • Lead and execute instrument qualification work as required
  • Develop and execute QC studies and write reports
  • Once qualified as a trainer, perform cross training of other technologists
  • Lead on Lab investigations and Deviations
  • Perform routine maintenance on laboratory instruments
  • Follow established procedures for chemical receipt, inventory, use and discard
  • Troubleshoot methods and equipment as required
  • Author procedural changes using the change control program
  • Review raw data and audit trails
  • 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 according to established procedures
  • 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
  • Assisting Supervisors on Laboratory investigations and Deviations
  • Perform all other related duties as assigned

Requirements:

  • Strong understanding of GMP, GLP, 21 CFR, ICH, Pharmacopeial and Regulatory guidelines
  • Advanced knowledge and practical experience in protein analysis such as 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 the fast-paced laboratory environment
  • Able to multi-task and very flexible based on the 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
  • High quality technical writing

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

Behavioural Competencies:

  • Teamwork: Working effectively and productively with others
  • Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types
  • Problem Solving: Anticipating, analysing, diagnosing and resolving problems
  • Flexibility: Agility in adapting to change. Ability to work independently
  • Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
  • Written Communication: Writing clearly, succinctly and understandably
  • Decision Making: Utilizing effective process to make decisions
  • Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives