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Senior Analyst, Quality Control

National Resilience

National Resilience

IT, Quality Assurance
Mississauga, ON, Canada
Posted on Thursday, January 18, 2024

A career at Resilience is more than just a job – it’s an opportunity to change the future.

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.

For more information, please visit www.resilience.com

Position 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
• Performs all other related duties as assigned

Minimum Qualifications:

• 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

Demonstrated ability to apply the following behavioural competencies on the job:

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

This job profile provides an overview of the minimum requirements of the job and does not include all the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Resilience offers employees a robust 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. Our target annualized base pay hiring range for this position is $70,000.00 - $103,750.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.