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About the role
Key responsibilities & impact- Perform quality assurance and training functions under the direct supervision of the Quality Systems Manager
- Review equipment quality-control and maintenance records weekly
- Document, investigate, and perform root-cause analysis for deviations and customer complaints related to product quality or donor safety
- Inspect and release incoming supplies and investigate supplies that do not meet specifications
- Review documentation for unsuitable test results
- Ensure compliance with cGMP regulations, SOPs, and regulatory requirements
- Perform product release activities
- Review lookback information and documentation
- Review waste shipment documentation
- Review unexpected plasmapheresis events and electronic donor chart exceptions
- Review donor deferral notifications from competitor centers
- Review plasma processing documentation for freezing, storage, and handling
- Create, maintain, and audit training records and files
- Perform employee training observations to verify competency
- Conduct training for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations
- When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with internal donor center audits
- Review monthly trending reports and donor adverse-event reports
- Conduct training addressing donor center corrective and preventative measures
- Communicate issues identified during reviews to the CQM
Requirements
What you’ll need- High school diploma or GED
- Typically requires no previous related experience
- Must obtain state licensures or certifications if applicable
- Donor Center Technician certification must be maintained
- Developing interpersonal communication, organizational, and problem-solving skills
- Ability to understand FDA regulations
- Strong integrity and commitment to quality and compliance
- Good knowledge of mathematics
- Proficiency with computers
- Ability to work flexible scheduling to meet business needs
- Ability to understand and follow SOPs and protocols
- Basic understanding of cGMP and quality systems
- Ability to review documentation for accuracy for extended periods
- Ability to perform employee observations and basic document review
- Ability to communicate issues to the CQM
- Ability to work independently with little guidance
- Ability to handle exposure to biological fluids, infectious organisms, laboratory equipment, and extreme cold
- Ability to perform required physical tasks, including sitting, standing, bending, twisting, frequent hand movements, occasional squatting/crouching, and lifting up to 50 lbs.
- Hearing acuity and correctable near and far vision required
- Ability to communicate and understand spoken information
Benefits
Comp & perks- Exposure to an international team and global healthcare company
- Equal employment opportunity protections
- Personal protective equipment provided/required, including protective eyewear, garments, gloves, and cold-gear