Quality Compliance Specialist-Bethlehem, PA

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 centers Quality Management System. The anticipated annual salary starts at $52300 and is commensurate with 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:

• Bachelors degree in biology Quality Assurance/Quality Management Healthcare Administration Public Health or a related field is required.
• 35 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 drivers license with reliable transportation.

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.

Required Experience:

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