Senior Analyst, Quality Control

National Resilience; Mississauga; On-site; CAD 70,000 - 104,000; Full time

Job summary

A biomanufacturing company in Mississauga is seeking a Senior Analyst, Quality Control. This full-time role involves performing QC testing on biologics, ensuring compliance with industry regulations, and supporting method development. Ideal candidates will have substantial QC experience and expertise in analytical techniques. A comprehensive benefits package and competitive salary range are offered.

Benefits

Annual cash bonus

Competitive healthcare

Flexible time off

Qualifications

• Significant QC or Analytical Development experience within biopharma/biotech (GMP environment).
• Hands-on expertise with two or more of HPLC, icIEF, ELISA, etc.
• Strong knowledge of FDA, EMA, ICH guidelines, and data integrity.

Responsibilities

• Perform QC testing of biologics using various analytical techniques.
• Ensure compliance with cGMP / GLP, FDA, EMA, ICH guidelines.
• Lead deviations, OOS / OOT investigations, and RCA.

Skills

QC testing expertise

Analytical problem-solving

Excellent communication skills

Knowledge of cGMP / GLP

Education

Bachelor of Science (B.Sc.) in Biology, Biochemistry, or related field

Tools

HPLC

ELISA

PCR/qPCR

Job description

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.

Position Summary :

We are seeking an experienced Senior Analyst, Quality Control with expertise in biological testing to join our Quality Control team in Mississauga, ON. This is a full-time, onsite position.

Position Responsibilities :

• Perform QC testing of biologics using: Chromatography (HPLC / UPLC - SEC, RPHPLC, IEX), Capillary Electrophoresis (icIEF, CE-SDS), Immunoassays (ELISA - binding, potency; Western Blot), Molecular Biology (PCR, qPCR), Spectroscopy (UV-Vis, FTIR), Physicochemical Testing (Appearance, pH, osmolality, TOC, sub-visible particle analysis - HIAC).
• Ensure compliance with cGMP / GLP, FDA, EMA, ICH, and Health Canada guidelines.
• Analyze data, document results, and maintain ALCOA+ data integrity standards.
• Support method development, validation, transfer, verification, and troubleshooting.
• Lead deviations, OOS / OOT investigations, and root cause analysis (RCA).
• Author/review SOPs, test methods, protocols, and technical reports.
• Participate in regulatory audits (FDA, EMA, Health Canada).
• Train and mentor junior analysts.
• Collaborate with QA, Manufacturing, and MSAT teams.
• Maintain and calibrate analytical instruments (HPLC, icIEF, etc.), if needed.
• Interact with clients for technical discussions and project support.

Minimum Qualifications :

• Significant QC or Analytical Development experience within biopharma/biotech (GMP environment).
• Hands-on expertise with two or more of the following: HPLC / UPLC (SEC, IEX, RPHPLC), icIEF, CE-SDS, ELISA (quantitative, potency), Western Blot, PCR / qPCR, UV-Vis, FTIR, sub-visible particle analysis (HIAC), Physicochemical tests (pH, TOC, osmolality, appearance).
• Strong knowledge of GMP / GLP, FDA / EMA / ICH guidelines, and data integrity (ALCOA+).
• Excellent analytical, troubleshooting, and problem-solving abilities.
• Strong written / verbal communication skills for cross-functional and client interactions.
• Ability to work in a fast-paced, compliance-driven environment.

Preferred Qualifications :

• Bachelor of Science (B.Sc.) in Biology, Biochemistry, or related field.

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, occasional extended shifts, and possible short-notice schedule changes.

BEHAVIOURAL :

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, analyzing, 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 processes 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 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 encouraged to communicate their needs/requirements to Human Resources.

Resilience offers employees a comprehensive total rewards program including equity, an annual cash bonus, RRSP / DPSP with a generous company match, competitive healthcare, dental, vision, life, LTD, and AD&D benefits, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up, tuition reimbursement, and employee referral program. The target base pay range for this position is $70,000.00 - $103,750.00 per year, dependent on factors such as location, experience, qualifications, skills, and knowledge. We encourage interested candidates to apply and start a conversation with our recruiters.