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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in current Good Manufacturing Practices (cGMP) and validation processes, with strong analytical and communication skills to ensure compliance and effective collaboration in donor center environments.
Highest-signal resume keywords
Current Good Manufacturing Practices (cGMP)Validation Protocol PerformanceOperational Qualification/Performance Qualification TestingAnalytical SkillsMicrosoft Office Applications
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation DocumentationTest Case WritingData AnalysisProcess EvaluationEquipment CalibrationValidation ReportingCritical Control PointsUser RequirementsFunctional DesignsRegulatory Compliance
Soft Skills
Oral CommunicationWritten CommunicationCritical ThinkingProblem-SolvingTeam Collaboration
Industry Keywords
Quality SystemsHealth CanadaDonor Center OperationsField QualityManufacturing Environments
About the role
Key responsibilities & impact- 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
What you’ll need- 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