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Quality Manager – Plasma Center
GrifolsQuality Systems Manager overseeing quality management and compliance at plasma donor center. Collaborating with management to ensure safety, quality, and regulatory adherence.
About the role
Key responsibilities & impact- Maintains oversight of the center’s quality management system and ensures continuous quality improvement
- Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations
- Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance
- Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained
- Responsible for the personnel functions of the Quality Systems Associate
- Responsible for oversight of all aspects of internal and external audits
- Continuously assesses, promotes, and improves the effectiveness of the quality and training systems
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints
- Investigates identified trends and performs follow-up on corrective and preventive actions
- Oversees product and biohazard waste shipments
- Performs a review of the documentation of unsuitable test results and unit lookback information
- Ensures that job and center annual training is completed, documented, and on file
- Performs employee training observations to ensure staff competency
- Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions
- Initiates rejection of supplies for non-compliance
- Determines donor suitability activities and manages donor deferrals as appropriate
- Prepares quality analysis reports to track issues and set goals
Requirements
What you’ll need- Bachelor of Science degree or equivalent
- Certified and proficient in quality and compliance
- Typically requires 2-5 years of related experience in a medical and/or cGMP regulated environment
- Experience with plasma or whole blood
Benefits
Comp & perks- full healthcare benefits
- tuition reimbursement
- some of our Academy courses even count for college credit
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality management systemStandard Operating Proceduresroot-cause analysisquality analysis reportsregulatory complianceinternal auditsexternal auditscorrective actionspreventive actionstraining systems
Soft Skills
collaborationoversightcommunicationproblem-solvingtrainingassessmentinvestigationdocumentationleadershiporganizational
Certifications
Bachelor of Science degreequality and compliance certification