Quality Compliance Specialist

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

Are you looking for a job that will have a positive impact in the lives of many people? Do you have a passion to work in a fast-paced, not-for-profit environment? Do you want to support our mission of saving lives? Then, Miller-Keystone Blood Center may be the right fit for you!

At MKBC, we save lives every day by providing blood products to hospitals in PA and NJ. The Quality Compliance Specialist position is responsible for ensuring compliance with regulatory requirements and quality standards within the blood center's Quality Management System. The anticipated annual salary starts at $52,300 and is commensurate with experience. In addition, Miller-Keystone offers the following to all full-time employees:

• 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!

What you will be doing:

• 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, medical evaluation forms, special collection documentation, validations, and competency records.
• Oversee Component Retrieval activities, including drafting and reviewing hospital correspondence, conducting retrieval reviews, supporting initial hospital notifications as needed, and serving as a backup resource for FDA reporting.
• Review and evaluate quality events, including complaints, defective materials, and other quality-related issues, to ensure appropriate documentation, investigation, follow-up, and resolution.
• Review donor notification letters for accuracy, consistency, and regulatory compliance, and develop new or revised notifications as needed.
• Prepare, compile, and maintain Biologics License Application (BLA) submissions, ensuring submissions are accurate, complete, well-organized, and compliant with FDA regulatory requirements.
• Develop, review, and maintain Standard Operating Procedures (SOPs) and related controlled documents within assigned areas of responsibility to ensure alignment with current practices and regulatory requirements.
• Support internal and external audits and regulatory inspections by preparing documentation, responding to information requests, coordinating follow-up activities, and assisting with the resolution of audit findings and corrective actions.

What you will bring to the role:

• Bachelor's degree in biology, Quality Assurance/Quality Management, Healthcare Administration, Public Health, or a related field is required.
• 3-5 years of experience required working within Quality Management Systems in a regulated environment, 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. Familiarity with FDA regulations and AABB standards and requirements is preferred.
• 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.
• Familiarity with Microsoft office suite is preferred.

Additional information:

This position reports to the Senior Director of Quality Assurance and will be based out of our Bethlehem location. They will be responsible for working the following schedule:

• The normal hours for this position are 8:30am-5pm.
• The expected travel for this position is up to 10%.
• Must hold a clear and valid driver's license with reliable transportation.
• This position is located in Bethlehem, PA and is fully onsite. Relocation expenses are not covered for this position.

EEO Statement

Miller-Keystone is proud to be an equal opportunity employer and is committed to creating a diverse environment. All qualified applicants are welcomed and will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law. It shall endeavor to provide reasonable accommodation requested by all employees with documented disabilities who are otherwise able to perform the essential functions of their jobs.