Quality Control OOS Investigator

Position: Quality Control OOS Investigator Role
Join the team as an OOS Investigator in Mississauga, ON, specializing in quality control and compliance initiatives. This role emphasizes your ability to manage out-of-specification investigations in a laboratory environment while upholding GMP standards.

Reporting directly to the Director/BUMA, the OOS Investigator will be pivotal in conducting timely and scientifically sound investigations within the Analytical Quality Control lab. Your knowledge in analytical methods and root cause analysis will help ensure compliance and maintain product integrity. You will be tasked with driving CAPAs and working collaboratively across teams to enhance quality processes.

Key Responsibilities:

• Execute OOS and OOT investigations adhering to GMP/GLP

• Identify root causes using RCA tools like Fishbone and 5-Whys

• Draft investigation reports and define corrective actions

• Coordinate with QA and QC teams for holistic process management

• Maintain inspection-readiness through effective documentation

Requirements:

•

B.Sc. or higher degree in Chemistry or related field

• At least 5 years of experience conducting laboratory investigations

• Strong analytical skills with familiarity in chromatography techniques

• Proficient in electronic documentation and LIMS systems

• Excellent organizational and writing skills

Utilize your analytical and technical expertise to drive improvements and support quality assurance within this vital role.
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