Senior Investigations Associate

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description TITLE: SENIOR INVESTIGATIONS ASSOCIATE SUMMARY: Initiates, leads, and coordinates complex investigations with key cross-functional parties related to Deviation Reports (DRs). Responds to Packaging and Processing deviations, provides technical leadership for root cause investigations, develops and authors trend reports to identify recurring issues, systemic gaps, and emerging risks, and recommends proactive improvements to enhance compliance and operational performance. ESSENTIAL FUNCTIONS: * Initiate and lead operational investigations into deviations with appropriate cross functional parties. * Perform root cause analysis of deviations through the use of RCA tools to identify the root cause. * Perform technical writing of investigation reports and trend reports. * Evaluate the thoroughness of investigations and determined root cause. * Propose Corrective Actions Preventative Actions (CAPAs) to ensure root cause of investigations are addressed and prevent recurrence of the event. * Collaborate cross functionally to support various documentation and training needs to ensure compliance to requirements. * Track, trend, and monitor metrics for deviation investigations and related processes to identify trends and associated actions to mitigate risks and drive performance. * Prepare and present periodic trend reports that summarize investigation data, recurring issues, root cause patterns, CAPA effectiveness, and opportunities for continuous improvement. * Ensure on time closure of assigned Investigations, CAPAs, Change Controls. * Support continuous improvement of the Investigation process through Practical Process Improvement (PPI) concepts. * Assist with regulatory / client audits as required. * Maintains a safe working environment and reports potential hazards. * Performs alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS EDUCATION: * Bachelor's degree in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment or College/Technical School diploma in pharmaceutical manufacturing, science or related field. EXPERIENCE: * Minimum 5 years of manufacturing experience in the pharmaceutical, food, or cosmetic industry, including demonstrated experience leading complex investigations, technical/scientific writing, trend analysis, and cross-functional collaboration. * Previous experience in technical or scientific writing an asset. Compensation The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.

Conduct internal, external, and client GMP audits while preparing detailed reports on findings. Manage audit observations and CAPAs while providing administrative support for ongoing compliance projects.

Requires a Bachelor of Science degree in chemistry, biology, pharmacy, or a related field. Candidates must have a minimum of 3 years of experience in GMP/GLP auditing.

• Data analysisPreferred
• CommunicationPreferred

Identified from the job description. Confirm important requirements above.

• Good Manufacturing Practices
• GMP Auditing
• GLP
• Regulatory Compliance
• FDA Compliance
• Quality Investigation
• FMEA
• Fishbone Diagram
• SAP
• Technical Writing
• Audit Management
• CAPA
• Regulatory Inspections
• Data Analysis
• Communication
• Organizational Skills
• Equipment Operation
• Good Laboratory Practice (GLP)
• Administrative Support
• Workflow Management
• Chemistry
• Auditing
• Biology
• Management
• Corrective And Preventive Action (CAPA)
• English Language
• Failure Mode And Effects Analysis
• Problem Solving
• Key Performance Indicators (KPIs)
• Microsoft Office
• Personal Protective Equipment
• Safety Standards
• SAP Applications
• Timelines
• Verbal Communication Skills
• Scheduling
• Environment Health And Safety
• Investigation
• Prioritization
• Detail Oriented

• Manufacturing
• Healthcare
• Science & Research
• Administrative
• Security & Safety
• Investigations Assistant
• Compliance Auditor
• Accountants
• Accountants and Auditors

Minimum education

Bachelor’s degree

Minimum experience

2+ years

Posting language

English

Working hours

40 hours per week