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Senior Analyst, Quality Control
2 months ago
Biomanufacturing Specialist
A career at Resilience is more than just a job - it's an opportunity to change the future. As a Biomanufacturing Specialist, you will play a critical role in shaping the future of medicine.
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.
Key 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
- Develop and execute QC studies and write reports
- Lead and execute instrument qualification work as required
- Assist Lab management in internal, client and regulatory audits
- 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
- 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 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
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
Resilience offers a comprehensive total rewards program, including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.