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.

KNOWLEDGE / SKILLS / ABILITIES: 

1. Bachelor’s degree from an accredited college or university in a related field, plus two (2) years of experience in quality assurance within the blood banking industry, or
2. Associate’s degree plus four (4) years of experience in blood banking, quality or bioscience field, or an equivalent combination of education and experience sufficient to perform the essential job duties.
3. Prior work experience in a blood center or hospital laboratory environment highly desirable.
4. Must be self-motivated, dependable, punctual, and have demonstrated effective organizational and communication skills.
5. Must be familiar with FDA regulations governing blood banking, AABB standards, OSHA regulations, and Good Manufacturing Practice (cCGMP).
6. Must demonstrate a positive approach toward donors and other team members, acting in a highly professional manner at all times.
7. Must maintain confidentiality of various information at all times. 
8. Must be able to proactively identify collaborative solutions to facilitate resolution of conflicts. 
9. Must be able to evaluate processes (e.g. financial, compliance, lean) for improvement.

PHYSICAL DEMANDS / WORKING CONDITIONS / ENVIRONMENT:

1. Work is generally performed in a office setting, with active prescence throughout the organization.
2. Routine work schedule, with occasional after hours on-call rotation.
3. Low risk of exposure to infectious diseases from blood and blood products.  Work is generally performed in corporate office environment.
4. Requires occasional travel within the community or to other centers and facilities; must possess a valid driver’s license and be insurable by our commercial auto insurance carrier.

The requirements and physical demands listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made in accordance with the ADA to enable individuals with disabilities to perform the essential job functions.

Disclaimer: The above information on this description has been designed to indicate the general nature and level of work performance by employees within this classification. It is not designed to contain or be interpreted as comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.