Quick Interview: view Salary range: $55,000 to $70,000 Willing to relocate: No Years of related job experience: 9 Highest degree earned: Master's Accreditations: AATB Certified Tissue Banking Specialist, Languages: English Software: Proficient in all Microsoft Office operations
We're delighted to have the opportunity to present this professional candidate through resume and experience within the regulatory and compliance field. A former Director of Quality Assurance and Regulatory Affairs within the human tissue banking arena, she brings 9 years of extensive experience and is ready for new and exciting challenges within the regulatory field.
EMPLOYMENT HISTORY
Organization: Please reach us for these details! Location: Nashville, TN Job title: Director of Quality Assurance and Regulatory Years and months employed: 9 Year(s) 10 Month(s) Responsibilities: Assumed overall responsibility for all aspects of Quality Assurance/Quality Control for Tissue Services including donor records.
Directly supervised all Quality and Regulatory staff (20).
Responsible for the review and maintenance of all Tissue Service SOP’s.
Maintained regulatory compliance with federal, state, local, and voluntary
accreditation organizations.
Traveled extensively throughout the United States in conjunction with serving
as a primary escort for all regulatory inspections.
Oversaw the performance of the internal and external Quality Audit Program.
Oversaw all regulatory inspections and accredididation processes.
Reported to Medical Advisory Board concerning budgetary and potential issues of a medical natures.
Organization: DCI Donor Services Location: Nashville, TN Job title: Compliance Manager Years and months employed: 9 Year(s) 10 Month(s) Responsibilities: Ensured DCIDS Tissue Services was in compliance with all federal regulations,standards, and state laws.
Completed supplier quality audits and certifications.
Maintained SOP Manual and drafted new standard operating procedures and forms, at they pertained to regulations and standards. Maintained change history files.
Stayed abreast of industry changes to comply with current good tissue practices for all regulatory agencies (via annual conferences, monthly updates, and publications).
Worked closely with a wide variety of personnel including staff and management.
Oversaw and maintained an ongoing audit program, both external and internal.
Advised Tissue Services’ Department Heads of necessary steps to achieve compliance goals in response to audit findings.
Traveled extensively and served as primary escort and correspondent for inspections by accrediting, licensing, regulatory, and partner agencies.
Drafted correspondence to accrediting, licensing, regulatory, and partner agencies on audit and inspection findings. Pursued licensure/renewals for product distribution.
Oversaw validation proceedings and the Equipment Maintenance and Monitoring Program to ensure timely completion of necessary monitoring per DCIDS SOP’s, AATB standards, and FDA regulations.
Reviewed/approved validation protocols and monitoring logs prior to implementation.
As Safety Officer for all regions, in charge of overseeing the OSHA Program.
Organization: DCI Donor Services Location: Nashville, TN Job title: Compliance Coordinator Years and months employed: 9 Year(s) 10 Month(s) Responsibilities: Maintained validation and monitoring schedules to ensure timely completion of necessary monitoring per DCIDS standard operating procedures, AATB standards, and FDA regulations. Aided in the writing and implementation of SOP’s for newly validated and qualified equipment.
Worked closely with staff and management. Advised department heads of necessary steps to achieve compliance goals.
Drafted correspondence to accrediting, licensing, regulatory, and partnering agencies on audit findings. Pursued licensure for product distribution in additional states.
Served as primary escort for inspections by accrediting, licensing, regulatory, and partner agencies, traveling extensively throughout the United States.
Maintained pertinent vendor information to ensure qualified vendors were used for supplying sterile supplies. Maintained certificates and sterility claims on file.
Oversaw the Safety Program to ensure compliance with OSHA requirements.
EDUCATION
Institution Name: Tennessee State University Location: Nashville, TN Degree earned: Master's Major/Concentration: Biology Year Graduated: 2002
Institution Name: Fisk University Location: Nashville, TN Degree earned: Bachelor of Arts Major/Concentration: Biology Year Graduated: 1992
