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.

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.

• 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.