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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 problem-solving skills to ensure compliance and operational efficiency in donor center environments.
Highest-signal resume keywords
Current Good Manufacturing Practices (cGMP)Validation ExperienceWalk-In Freezer Thermal MappingQuantitative And Analytical 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 Protocol PerformanceOperational Qualification TestingPerformance Qualification TestingTest Case WritingValidation Report PreparationProcess EvaluationEquipment Calibration TrackingData AnalysisCorrective Action IdentificationTraining Preparation
Soft Skills
Oral Communication SkillsWritten Communication SkillsCritical ThinkingProblem-SolvingTeam Collaboration
Industry Keywords
Quality SystemsDonor Center OperationsBiological Fluids HandlingLaboratory EnvironmentManufacturing Environment
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 and Performance Qualification testing
- Interact with Donor Center and Field Quality/Operations personnel to facilitate timely, documented validation approval
- 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 compliance and cGMP issues to Field Quality/Operations and Quality Assurance personnel
- Write test cases for critical control points, user requirements, and functional designs
- Execute test cases and prepare validation reports for distribution
- Ensure assigned project milestones and timelines are met
- Evaluate processes, systems, and individual center equipment needs and participate in final approval processes
- Prepare validation equipment for Donor Center use and evaluate equipment upon return
- Identify actions to add, remove, or revalidate processes, systems, and equipment
- Evaluate new or updated methodologies, applications, and equipment and help resolve performance, transfer, or service issues
- Track and monitor process/system failures and events and provide feedback to Donor Center management
- Track equipment calibration due dates and calibration failures/events and provide related feedback to Donor Center management
- 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
- Must have experience with walk-in freezer thermal mapping
- 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 handle exposure to biological fluids, potential infectious organisms, extreme cold below 32°F, and high noise levels
- Ability to perform repetitive hand and foot movements and precise coordinated movements
- Ability to lift and carry up to 50 lbs
- Ability to communicate complex information and follow written or oral instructions/procedures
- Ability to travel on-site to plasma donation centers up to 50%–75% as needed
Benefits
Comp & perks- Regular full-time employment
- International team environment
- Exposure to validation work across plasma donation centers and affiliated locations
- Personal protective equipment provided/required, including protective eyewear, garments and gloves