Senior Specialist, QA Material Disposition

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

Benefits offered by this job

Annual cash bonus

RRSP/DPSP with company match

Comprehensive health, dental, vision,;

Life, LTD, AD&D benefits

Tuition reimbursement

Paid vacation & holidays

Employee referral program

Job summary

Resilience is seeking a Senior Specialist, QA Material Disposition in Mississauga to lead expert-level reviews of raw materials and disposition decisions in line with cGMP and site SOPs.

The role involves investigations into discrepancies, OOS, and deviations, plus preparing for regulatory inspections and audits. Collaboration with Manufacturing, QC, and Supply Chain is essential.

Qualifications

• 4+ years of progressive QA Material Disposition experience in a GMP-regulated biopharmaceutical or pharmaceutical environment.
• Experience with computerized systems supporting quality and manufacturing operations (e.g., Veeva Vault QMS, LIMS, SAP).
• Knowledge of GMP regulations including Health Canada, FDA, and EMA/EU Annex 1 requirements.
• Authorship and approval of SOPs and controlled documents related to material disposition.

Responsibilities

• Review and approve raw material records, testing data, and related documentation for release decisions (release, hold, or reject).
• Lead disposition-related investigations, root cause analysis, and timely CAPA closure.
• Provide regulatory submission support and stability program有关 material release activities.
• Serve as QA Material Disposition SME during regulatory inspections and audits.
• Review Change Controls and related SOPs for material records.

Skills

QA Material Disposition

GMP compliance

Investigations & CAPA

Regulatory inspections

SOPs & documents

English communication

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or Chemistry

Tools

Veeva Vault QMS

LIMS

SAP

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. For more information, please visit www.resilience.com

Brief Job Description

The Senior Specialist, QA Material Disposition reports to the Manager, QA Batch Disposition. This position provides expert-level review and disposition of materials at RBI Mississauga, ensuring all records, investigations, and associated quality documents are complete, accurate, and compliant prior to disposition. The Senior Specialist operates with a high degree of independence, leads complex disposition-related investigations, and is a key resource for regulatory inspection readiness.

Job Responsibilities

Core Responsibilities

Responsible for raw material approval, including the creation, review, and revision of material specifications, evaluation of compendial information, assessment of supplier documentation, and maintenance of approved raw material records in accordance with GMP and regulatory requirements. Perform independent, in-depth review of raw material records, testing data, laboratory records, and associated documentation for compliance with approved procedures and specifications. Make disposition decisions (release, rejection, or hold) in compliance with cGMP requirements and site SOPs. Identify, initiate, and lead investigations related to discrepancies, OOS results, deviations while driving root cause identification and timely CAPA closure. Review and approve deviation reports, OOS investigations, and CAPAs associated with material disposition activities. Support material release activities for regulatory submissions and stability programs. Provide oversight of GMP areas and shop floor support, as required.

Documentation & Regulatory Support

Review and approve Change Controls, including Supplier Change Notifications and SOPs related to material records. Review and approve QC SOPs, work instructions, and controlled documents. Serve as QA Material Disposition SME during regulatory inspections, corporate and client audits. Compile and report QC material metrics including right-first-time rates, review cycle times, and recurring defect trends.

Training & Development

Acquire and maintain all required certifications and qualifications for the assigned work area. Communicate material disposition decisions and outstanding items to Manufacturing, QC, MSAT, and Supply Chain stakeholders in a timely manner.

Minimum Qualifications

Advanced knowledge of material record review and disposition processes. Demonstrated independent experience and in-depth knowledge of cGMP requirements for biopharmaceutical material release (Health Canada, FDA, PMDA). Demonstrated experience leading investigations related to material disposition discrepancies, OOS results, and deviations. Demonstrated authorship and approval of SOPs and controlled documents related to material disposition. Strong critical thinking, attention to detail, and risk assessment skills. Excellent written and verbal communication skills for cross-functional stakeholder engagement. Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.

Preferred Qualifications

Bachelor's degree or higher in Life Sciences, Chemistry or a related scientific discipline. 4+ years of progressive QA Material Disposition in a GMP-regulated biopharmaceutical or pharmaceutical environment. Experience with computerized systems supporting quality and manufacturing operations (e.g., Veeva Vault QMS, LIMS, SAP). Knowledge of GMPs regulations including Health Canada, FDA, and EMA/EU Annex 1 requirements. Experience participating in regulatory inspections in an active role is an asset.

Physical & Work Environment

Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs. Physical demands may include lifting up to 10 lbs.

Accessibility and Total Rewards

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.

Company Information

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.