Quality Systems Manager for Plasma Center
About The Position
The Quality Systems Manager evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions at a plasma donor center. The role reports to the Regional Quality Manager and maintains oversight of the center’s quality management system, ensuring continuous improvement and compliance with applicable state, federal, and company regulations. The manager collaborates with the Center Manager to maintain product quality, donor suitability, and donor safety. The position oversees audits, investigations, corrective and preventive actions, training, donor suitability and deferral processes, quality documentation, regulated shipments, and supply quality. It also supervises the Quality Systems Associate, prepares quality analysis reports, and leads monthly quality meetings. The role is based in a plasma center in Portland, Oregon, and may require travel to meetings, events, and other centers.
Requirements
- Bachelor of Science degree or equivalent.
- Certified and proficient in quality and compliance.
- Typically 2–5 years of related experience in a medical and/or cGMP-regulated environment.
- Experience with plasma or whole blood.
- Strong interpersonal communication, organizational, and problem-solving abilities.
- Ability to understand and assess FDA regulations.
- Strong integrity and commitment to quality and compliance.
- Full command of mathematics and legible handwriting.
- High proficiency with computers.
- Proficiency in root-cause analysis and corrective and preventive actions.
- Ability to balance competing priorities and strong time-management abilities.
- Proven ability to maintain quality and compliance and contribute to the center leadership team.
- Ability to work with minimal supervision.
- Ability to travel as needed for meetings, events, and occasional support of other centers.
Responsibilities
- Maintain oversight of the center’s quality management system, address deficiencies promptly, and communicate concerns to appropriate parties.
- Direct and monitor processes for compliance with applicable state, federal, and company regulations; implement quality-control and compliance SOPs.
- Collaborate with the Center Manager to maintain product quality, donor suitability, and donor safety.
- Manage personnel functions for the Quality Systems Associate, including work direction, assignment, hiring, development, training, discipline, termination, records, scheduling, and task follow-up.
- Oversee internal and external audits, including preparation, execution, responses, corrective and preventive actions, assessment, and follow-up.
- Assess and improve quality and training systems by identifying trends, investigating procedural failures, and conducting direct observations.
- Document and investigate deviations and customer complaints, including root-cause analysis related to donor safety and product quality.
- Investigate trends and follow up on corrective and preventive actions, system implementations, and process improvement plans to assess effectiveness.
- Oversee product and biohazard waste shipments; verify regulatory specifications, product release requirements, labeling, and documentation, and authorize final shipment.
- Review unsuitable test-result documentation and unit lookback information.
- Review donor adverse-event reports and related documents.
- Ensure annual job and center training is completed, documented, and on file.
- Observe employee training to verify competency before releasing employees to work independently.
- Verify that supplies and materials meet quality requirements and are stored appropriately; initiate investigations and reject noncompliant supplies as needed.
- Determine donor suitability activities, manage donor deferrals, and review and approve deferred-donor reinstatement activities.
- Prepare quality analysis reports to track issues and set goals, and research and analyze systemic compliance issues.
- Ensure CLIA proficiency test surveys, complaint investigations, and training are properly documented.
- Hold monthly quality meetings to communicate status updates and manage action outcomes.
- Lead projects and initiatives as requested.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- Paid holidays
- Tuition reimbursement
- Up to 5% 401(k) match
- Eligibility to participate in up to 20% of the company bonus pool
- Opportunities for professional growth and career progression
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
