Senior Analyst, QC Compliance

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

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.

• Pre-employment medical and medical re-examination, inclusive of eye examination and color blindness test, performed every 2 years or as per Resilience's SOPs

• 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.

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. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.