Quality Compliance Leader for Life-Saving Programs

Hospital Central Services Cooperative, Inc.; Delta Manor (PA); On-site; USD 47,000 - 58,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Benefits

Prescription Plan

Flexible Spending Accounts

Life Insurance

Long Term Disability Insurance

Vacation, Personal and Sick Days

Fitness/Gym reimbursement

Retirement Savings Plan

And Much More!

Job summary

Miller-Keystone Blood Center in Bethlehem, PA, is seeking a Quality Compliance Specialist to ensure regulatory and quality standards within the QA system. The role involves assessing CQI deviations, supporting records reviews, and contributing to BLA submissions, while maintaining SOPs and documentation.

This full-time, onsite position reports to the Senior Director of Quality Assurance. Ideal candidates hold a biology or QA-related degree with 3–5 years in regulated quality management

Qualifications

• Bachelor's degree in biology or related field plus QA/QMS experience in regulated settings.
• Experience with deviation management, CAPA, change control and investigations.
• Familiarity with FDA regulations and AABB standards is preferred.
• Strong written and verbal communication skills for reports and audits.

Responsibilities

• Conduct initial assessments and final quality reviews of CQI deviations, ensuring documentation is complete and compliant with procedures and regulations.
• Support Medical Director in reviewing medical and regulatory records, donor documentation, and related forms.
• Oversee retrieval activities, draft hospital correspondence, and backup FDA reporting as needed.
• Review quality events, complaints, and defective materials, ensuring proper documentation and follow-up.
• Review donor notification letters for accuracy and regulatory compliance, update as needed.
• Prepare and maintain Biologics License Applications (BLA) submissions compliant with FDA requirements.
• Develop, review, and maintain SOPs and controlled documents to stay current with standards.
• Assist with internal/external audits and regulatory inspections, addressing findings and corrective actions.

Skills

Quality Management Systems

Regulatory compliance

CAPA

Change control

Analytical thinking

Microsoft Office

Technical writing

Education

Bachelor's degree in biology / QA/Quality Management / Healthcare Administration / Public Health

Job description

Miller-Keystone Blood Center in Bethlehem, PA, is seeking a Quality Compliance Specialist to ensure regulatory and quality standards within the QA system. The role involves assessing CQI deviations, supporting records reviews, and contributing to BLA submissions, while maintaining SOPs and documentation.

This full-time, onsite position reports to the Senior Director of Quality Assurance. Ideal candidates hold a biology or QA-related degree with 3–5 years in regulated quality management