EHS Specialist advancing workplace safety analytics, injury claims, audits, and compliance at LifeLabs, a Canadian healthcare organization. Improving employee well - being through data - driven safety programs.
About the role
- Validation Specialist executing cGMP validation, qualification testing, and reporting for Grifols’ plasma donor centers. Supporting Health Canada compliance across Canada.
Responsibilities
- Ensure current Good Manufacturing Practices (cGMP) and Health Canada/Grifols Quality Systems are followed during validation protocol performance, documentation, and review
- Travel to donor center sites to perform Operational Qualification/Performance Qualification testing
- Interact with Donor Center and Field Quality/Operations personnel to facilitate timely, documented validation approval
- Assist in keeping validation approaches current with regulatory expectations and industry standards
- Execute freezer installation, operational, and performance qualifications on-site
- Analyze validation data to ensure acceptance criteria are met and participate in writing validation summaries
- Communicate with Field Quality/Operations and Quality Assurance personnel regarding compliance and cGMP issues
- Write and execute test cases for critical control points, user requirements, and functional designs
- Prepare validation reports for distribution
- Ensure milestones and timelines are met on assigned projects
- Participate in evaluating processes, systems, and donor center equipment needs and final approval
- Prepare validation equipment for use and evaluation upon return
- Assist in identifying processes, systems, and equipment requiring addition, removal, or revalidation
- Track and monitor process/system failures and equipment calibration due dates and failures/events
- Provide feedback to Donor Center management on requirements, results, calibration, and validation processes
- Prepare donor center staff for validation activities and conduct training where applicable
Requirements
- Bachelor's degree
- Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures
- Excellent quantitative and analytical skills
- Excellent oral and written communication skills
- Strong critical thinking and problem-solving skills
- Ability to identify errors and provide corrective action
- Ability to work with others in a team environment
- Knowledge of Microsoft Office applications and computer applications used in the Donor Centers
- Ability to work in office and laboratory/manufacturing environments
- Ability to use required personal protective equipment
- Ability to lift and carry objects up to 50 lbs
- Willingness and ability to travel on-site to plasma donation centers up to 50%–75% as needed
- Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of stated requirements
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