Lead QC Compliance Investigator

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

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