Job Responsibilities

Investigations, Deviations & CAPA

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.
Collaborate with Quality Assurance, Manufacturing, Validation and other cross-functional teams to complete quality records within assigned due dates.

Documentation & Document Control

Review QC laboratory logbooks to ensure completeness, accuracy, and compliance with Good Documentation Practices (GDP) and data integrity requirements.
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.
Author and review SOPs, Test Methods, and other controlled documents.

Data Review, Trending & Reporting

Compile and evaluate QC data for Annual Product Quality Reviews (APQRs).
Generate quality trend reports for Water system, EM and LIR to identify recurring issues and improvement opportunities; present findings and recommendations to management.
Identify systemic quality trends and lead cross-functional initiatives to address root causes.

Inspection & Audit Readiness

Serve as QC Microbiology SME during regulatory inspections (Health Canada, FDA, EMA) and client audits.
Report significant quality events, regulatory concerns, or systemic compliance issues to the Manager, QC Compliance.

Technical Leadership & Development

Mentor and coach Analyst II, Analyst, and Technician team members on quality systems, investigation practices, and GMP documentation requirements.
Execute QC compliance projects and perform routine laboratory testing as required to support departmental objectives.
Act as compliance advisor to QC Microbiology, building alignment across QC, QA, and Manufacturing on investigation conclusions, risk assessments, and remediation approaches.

Experience & Education

Minimum Qualifications

Advanced knowledge and demonstrated expertise in QC compliance and quality management systems, including OOS and deviation investigation, CAPA, change control, and document control.
Demonstrated authorship of SOPs, Test Methods, and Change Controls.
Advanced technical report writing and data analysis.
Proficiency in Microbiology 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.
Demonstrated experience supporting regulatory inspections and internal audits.
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 Qualifications

Bachelor's degree or higher in Microbiology, Life Science, or a related scientific discipline; M.Sc. is preferred.
4+ years of progressive QC Microbiology experience (including compliance) in a GMP-regulated biopharmaceutical or pharmaceutical environment.
Experience with electronic quality management and laboratory systems (e.g., Veeva Vault QMS, LIMS, SAP).
Knowledge of l GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP).
Experience presenting directly to regulators or clients in an active SME role during inspections is an asset.

Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes.
Physical demands may include standing for extended periods, ability to lift up to 20kg (44lbs), and working in cleanroom environments with appropriate gowning requirements.

Responsibilities