Job Summary The Investigation Specialist is responsible for conducting, documenting, and following up on investigations related to deviations, Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, laboratory anomalies, and other quality events, in accordance with GMP requirements and internal procedures.

Key Responsibilities:

- Manage investigations related to incidents, deviations, OOS, OOT, atypical results, and analytical anomalies.
- Conduct laboratory investigations using a scientific, structured, and risk-based approach.
- Collect, verify, and analyze data, analytical records, chromatograms, electronic logs, and other relevant information.
- Identify the root cause of events using tools such as the "5 Whys," Ishikawa/Fishbone diagrams, root cause analysis, and contributing factor assessment.
- Collaborate with Quality Control (QC) and Quality Assurance (QA) teams.
- Assess the potential impact of anomalies on product quality, safety, efficacy, and compliance.
- Define, implement, and track appropriate Corrective and Preventive Actions (CAPA).
- Draft explicit, comprehensive, and scientifically sound investigation reports that meet GMP requirements.
- Ensure compliance with data integrity principles (ALCOA+)



and established procedures.
- Participate in identifying trends and recurring issues to prevent the recurrence of events.
- Monitor deadlines, actions, and commitments associated with investigations.
- Participate in internal audits, regulatory inspections, and quality reviews by providing the necessary documentation.
- Contribute to the continuous improvement of analytical processes and the laboratory's quality system.
- Train or mentor analysts and staff on best investigation practices and GMP requirements.

Key skills: analytical and critical mindset, scientific rigor, ability to identify root causes, technical writing, priority management, knowledge of GMP, data integrity, and ability to work with multidisciplinary teams. Join us as a Spécialiste en investigations – Laboratoire pharmaceutique and be part of a passionate team dedicated to advancing healthcare through rigorous investigation, innovation, and unwavering commitment to quality!

Pay: $53,500.00-$112,000.00 per year

Benefits

- Flexible schedule
- On-site parking

Work Location: In person

📌 Spécialiste en investigations – Laboratoire pharmaceutique (Laval)
🏢 QuantiPharm
📍 Laval