Quality & Regulatory Auditor

POSITION SUMMARY:

Ensures the manufacturing processes of the Blood Center operation are in compliance with standards and regulations governing the blood banking industry and Company’s SOP’s. Accompanies all inspectors while on premises and provides records and information as needed. Reviews all Biological Product and Deviation Reports (BPDR) and Variance Reports and trends to determine errors in procedure(s) or training. Performs regular audits of all manufacturing areas and provides reports to the Executive Director of Quality. May chair the Center’s Safety Committee and function as Safety Officer for the location.

DUTIES AND RESPONSIBILITIES:

1. Assists with or conducts In-Service training for safety, cGMP, OSHA and quality assurance issues on a regular basis. The QAC may assist the departmental Coordinators in training activities, when needed.
2. Conducts regular audits of manufacturing areas to ensure that all LifeShare Blood Centers SOPs, policies, FDA and OSHA regulations, and AABB standards are followed. Audit reports are prepared and submitted to the ED as completed.
3. Reviews all Biological Product & Deviation Reports and Variance Reports on a timely basis, submitting completed report to the MD and QA Unit. The QAC follows up with the Departmental Coordinator on BPDRs to ensure that any necessary training was given to avoid further Variances of the error.
4. Ensures necessary In-Service training on new procedures is conducted to ensure implementation on a timely basis. Ensures technical training is given on any new equipment or process.
5. Serves as a resource to departments in regard to regulatory affairs and quality assurance issues. Must maintain a current and thorough knowledge and understanding of all SOP’s, policies, regulations and standards at all times.
6. May serve as the Safety Officer for the Center, chairing the Center's Safety Committee. Conducts investigations as necessary into incidents or accidents involving center staff.
7. As directed, accompanies any outside operational inspectors at all times while on premises, providing information or records, making a record of all areas inspected and discrepancies noted. Sends a report of all inspections to the Executive Director of Quality and center management in a timely basis following the inspection.
8. Takes immediate corrective action where there is a breech in current good manufacturing practice (cCGMP), SOPs or safety procedures which could jeopardize the safety of donors or staff or the quality of donor blood and blood components.
9. Ensures corrective action is taken on any discrepancies found during any internal or external inspection.
10. Attends meetings and seminars as necessary to maintain proficiency and knowledge of manufacturing areas and quality area as it pertains to the blood center.
11. Performs statistical analysis of the business including tracking and trending of performance indicators.
12. Models LifeShare’s mission and values, integrating them into daily decisions, behaviors and actions.
13. Promotes cooperation and communication within a team to achieve Company and departmental goals and deliverables.
14. Meet and exceed customer expectations and adhere to established quality practices while seeking to continually improve work performance.

1. Completes other assignments and duties as may be assigned.

CORE COMPETENCIES:

Customer Service	We make every decision and measure every outcome based on how well it serves our customers, both internal and external.
Coaching	We are committed to continuous investment in the personal and professional growth of our team members; we also ask our employees to actively take responsibility for their own self-development.
Communication	We communicate directly, honestly and respectfully, informing our teams and sharing feedback at all levels.