Quality Compliance Specialist
$52,300–$52,300 year
On-siteBethlehem, Pennsylvania, United States
Job Summary
Conduct initial assessments and final quality reviews of CQI deviations, ensuring documentation is complete, accurate, and compliant with internal procedures and applicable regulatory requirements. Provide support to the Medical Director in completing and reviewing medical and regulatory records, including laboratory reports, donor reentry approvals, and competency records. Oversee Component Retrieval activities, including drafting hospital correspondence, conducting retrieval reviews, and serving as a backup resource for FDA reporting. Review quality events, donor notification letters, and prepare Biologics License Application submissions to ensure regulatory compliance. Develop, review, and maintain Standard Operating Procedures, and support internal and external audits by preparing documentation and coordinating follow-up activities. This role reports to the Senior Director of Quality Assurance at Miller-Keystone Blood Center, based in Bethlehem, PA, with normal hours of 8:30am-5pm and up to 10% travel.
Required Qualifications
- Bachelor's degree in biology, Quality Assurance/Quality Management, Healthcare Administration, Public Health, or a related field
- 3–5 years of experience working within Quality Management Systems in a regulated environment
- Experience preferably in blood banking, healthcare, clinical laboratory, biologics, or a related industry
- Demonstrated experience with deviation management, CAPA, change control, regulatory compliance, and investigation documentation
- Ability to interpret technical information and communicate complex concepts in clear, user-friendly language
- Excellent written and verbal communication skills, including technical writing, business reporting, and professional presentations
- Ability to understand and follow instructions provided in written, verbal, diagrammatic, and scheduling formats
- Strong analytical and problem-solving skills, with the ability to interpret data and apply sound judgment when making decisions
- Ability to work effectively and collaboratively with a diverse group of employees and cross-functional teams
- Must hold a clear and valid driver's license with reliable transportation
- Must be available for up to 10% travel
Desired Qualifications
- Familiarity with FDA regulations and AABB standards and requirements
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