Senior Analyst, QC Compliance

Resilience; Mississauga; On-site; CAD 70,000 - 108,000; Full time

Benefits offered by this job

Annual bonus program

RRSP/DPSP with generous company match

Comprehensive healthcare package

Dental and vision care

Life, LTD, and AD&D benefits

Tuition reimbursement

Employee referral program

Job summary

Resilience Biotechnologies Inc. is seeking a Senior Analyst, QC Compliance to lead investigations and CAPAs for QC Chemistry and Raw Materials, draft trend reports, and ensure GMP and regulatory alignment. You will manage compendial updates, support APQR data, and close quality records with cross-functional teams.

The role requires mentoring junior staff and acting as SME during inspections. The candidate should have demonstrated leadership in OOS investigations, SOP authoring, and strong data

Qualifications

• Demonstrated experience as Lead Investigator/Author on OOS and deviation investigations with CAPA closure.
• Authorship of SOPs, Test Methods, and Change Controls.
• Advanced technical report writing and data analysis.
• Proficiency in chemistry analytical test methodologies.
• In-depth knowledge of cGMPs and compendial standards (USP, EP) and regulatory expectations.
• Coaching and mentoring Analyst-level staff.
• Ability to work independently with multiple priorities and complex tasks.
• Fluent English communication.

Responsibilities

• Act as primary Lead Investigator/Author on OOS, Laboratory, and Deviation investigations; lead Change Controls/CAPAs end-to-end.
• Review QC logbooks for completeness, accuracy and GDP compliance.
• Compile and evaluate QC data for APQRs.
• Generate quality trend reports for water system, LIR and LE.
• Author, review, and approve SOPs, Test Methods, and other documents.
• Manage compendial updates (USP, EP, JP) to keep methods and specs current.
• Collaborate with QA, Manufacturing, Validation to close quality records on time.
• Perform QC compliance duties and special projects including testing.
• Serve as QC Chemistry SME during regulatory inspections and audits.
• Mentor Analyst II/Analyst/Technician on GMP docs and investigations.
• Report Health and Safety incidents and obtain required certifications.

Skills

Lead Investigator/Author (OOS & Deviat

SOPs, Test Methods, Change Controls

Advanced technical report writing

Chemistry analytical test methods

cGMPs & compendial standards knowledge

Coaching Analyst staff

Independent work & multi-priority

English language proficiency

Education

Bachelor’s degree in Chemistry/Biochemistry or related science

M.Sc. preferred

Job description

Brief Job Description

The Senior Analyst, QC Compliance is responsible for supporting and maintaining compliance activities to ensure adherence to GMPs, regulatory requirements, and internal quality systems. This role leads and supports lab investigations, deviations, change controls and CAPAs for QC Chemistry and QC Raw Material departments. The Senior Analyst is also responsible for drafting and managing quality trend reports (Water, LIR, LE), managing compendial updates, compiling data for APQRs and conducting logbook reviews. The Senior Analyst collaborates with cross-functional teams to drive timely closure of quality events and maintain inspection readiness.

Job Responsibilities

• Act as primary Lead Investigator/Author on Out of Specification, Laboratory, and Deviation investigations; Lead Change Controls/CAPAs end-to-end including initiation, implementation, and closure.
• Review QC laboratory logbooks to ensure completeness, accuracy, and compliance with Good Documentation Practices (GDP) and data integrity requirements.
• Compile and evaluate QC data for Annual Product Quality Reviews (APQRs).
• Generate quality trend reports for water system, LIR and LE to identify recurring issues and improvement opportunities.
• Author, review, and approve SOPs, Test Methods, and other controlled documents.
• Manage the assessment, implementation, and documentation of compendial updates (e.g., USP, EP, JP), ensuring laboratory methods, specifications, procedures, and related documentation remain current and compliant.
• Collaborate with Quality Assurance, Manufacturing, Validation and other cross-functional teams to complete quality records within assigned due dates.
• Perform other QC compliance duties and special projects, including laboratory testing as assigned to support departmental and organizational objectives.
• Serve as QC Chemistry SME during regulatory inspections (Health Canada, FDA, EMA) and client audits.
• Mentor and coach Analyst II, Analyst, and Technician team members on quality systems, investigation practices, and GMP documentation requirements.
• Report Health and Safety incidents, accidents, or potential hazards.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Perform all other job-related duties as assigned.

Education, Qualifications, Skills, and Experience

• Minimum Requirements: Demonstrated experience as Lead Investigator/Author on OOS and deviation investigations with CAPA closure.
• Demonstrated authorship of SOPs, Test Methods, and Change Controls.
• Advanced technical report writing and data analysis.
• Proficiency in chemistry analytical test methodologies.
• In-depth knowledge of cGMPs, compendial standards (USP, EP), and regulatory expectations for biopharmaceutical drug product and drug substance testing.
• Demonstrated coaching and mentoring of Analyst-level staff.
• Ability to work with a high degree of independence and manage multiple priorities and complex tasks.
• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.

Preferred Background

• Bachelor’s degree or higher in Chemistry, Biochemistry, or a related scientific discipline; M.Sc. is preferred.
• Typically 4–6 years of progressive QC Chemistry experience (including compliance) in a GMP-regulated biopharmaceutical or pharmaceutical environment.
• Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP).
• Experience participating in regulatory inspections (e.g., Health Canada, FDA) in an active SME role is an asset.

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 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, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.

Our target base pay hiring range for this position is $70,000.00 - $107,500.00 per year.

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.

Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes.

Resilience is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.