Quality Compliance Specialist

HCSC•Bethlehem, PA

2d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Familiarity with FDA regulations and AABB standards and requirements is preferred.
Familiarity with Microsoft office suite is preferred.

Responsibilities

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.