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 clear, 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

Advantages:
Versatile schedule
In office parking

Work Location: In person

📌 Spécialiste En Investigations – Laboratoire Pharmaceutique Sainte Rose (Sainte-Rose)
🏢 QuantiPharm
📍 Sainte-Rose