Plasma Center Quality Manager

POSITION SUMMARY

Under minimal supervision, this position is responsible for assisting in managing the review of quality systems and compliance in all areas of technical and clinical operations. This position will monitor plasma center systems, procedures, practices and records for compliance with applicable local, county, state and federal regulations. The Quality Manager serves as a resource to operations on quality issues.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Perform all assigned duties in compliance with internal SOPS and external regulations. Bring compliance issues to the attention of management.

2. Assure quality customer service to all customers, including timely responses when necessary.

3. Review and approve procedures, policies, forms, etc. to ensure compliance with regulations. Approves any requested exceptions from SOP.

4. Plan and conduct internal audits of specific systems, processes and personnel performance for compliance with regulations, standards, and internal standard operating procedures (SOP). Prepare formal report and present findings. Review and approve any initial actions, root cause analysis and corrective action and tracks completion of corrective action. Perform follow up audits as required to verify effectiveness of completed actions.

5. Assist plasma center management in reporting, investigations, and analysis of deviations from established procedures. Determine if root cause analysis is required. Ensure documentation is clear, complete and factual and events are accurately coded. Review and approve any initial actions, root cause analysis and corrective action and tracks completion of corrective action. Work with operations to ensure deviations are managed appropriately and in a timely manner. When appropriate, complete all aspects of FDA Biological Product Deviations Reports (BPDR) and submit to FDA within required timelines.

6. Conduct data and process analysis activities including in-depth analysis of deviations and operational performance data. Evaluate data for trends and identifies opportunities for improvement.

7. Participate in external audits. When possible, Quality Manager will host audit. In addition, and in accordance with SOP, provide support in gathering needed information to ensure timely response to inspector, clarify issues when needed and record notes. Communicate status of inspection to Management. If necessary, lead the initiative to develop and submit a response to the audit. Ensure any findings are managed correctly with regard to Deviation Management.

8. Develop proficiency with, and apply, process improvement tools.

9. Assist with information gathering for regulatory submissions and annual reports to the FDA. Assist with management of recalls, market withdrawals, and lookbacks.

10. Perform reviews of documents to ensure processes are in control (Quality Control Data, Validations, Proficiency testing, Adverse Reactions, ETC).

11. Provide expert leadership with regard to application of new or revised regulatory requirements, CLIA requirements and PPTA Standards.

12. Participate in the supplier management system. Assist with supplier contact to complete a qualification survey and assess supplier qualification. Assist operations with supply or equipment recalls.

13. Assist in oversight of Information Services and Change Management.

14. Participate on review team to evaluate non-conforming products, materials or test results. Determine impact with regard to regulations and customer expectations. Ensure required actions are implemented.

15. Assist with resolving testing and quality control issues and submit corrective action to accrediting Agency, if necessary.

16. Present role of Quality to new employees; assist with presenting cGMP concepts.

17. Responsible for conducting quality reviews of operational records, both paper and electronic, to ensure compliance with standard operating procedures (SOPs) and regulatory requirements. This includes documentation related to donor suitability, plasma collection and processing, test result management, product labeling and shipment, quality control activities, and temperature monitoring.

18. Perform all other duties as assigned.

CUSTOMER INTERACTION/PROBLEM-SOLVING

Must maintain a high standard for conscientious, courteous, and enthusiastic service to internal and external customers. Must make customer's needs a high priority in face-to-face or telephone contact. Must consistently deliver service in a timely, accurate, professional, and friendly manner. Demonstrates a high level of problem-solving skills.

COMPLEXITY

Work includes varied duties requiring numerous unrelated processes and methods or substantial depth of analysis in an administrative or professional field. There are major areas of uncertainty in approach, methodology, or interpretation and evaluation processes caused by continuing changes, technological developments, conflicting requirements, or unknown phenomena. Work requires the origination of new techniques, establishing criteria, or developing new information. Occasionally, extensive analysis and probing are required to determine the nature and scope of problems, with concurrent or sequential activities involving others within or outside the organization.

NATURE AND EXTENT OF SUPERVISION PROVIDED TO THE POSITION

Overall, objectives and resource allocations are determined by the supervisor, providing broad administrative direction, with assignments given in terms of broadly defined missions or functions. Employee plans, designs and carries out programs, projects, studies, or other work independently. Results are considered technically sound by virtue of the employee's expertise, and are generally accepted with review only for conformity to objectives, contribution to program goals, or advancement of technological understanding.

QUALIFICATION REQUIREMENTS

To perform this job successfully, each essential duty (as identified above) must be performed satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

GENERAL KNOWLEDGE, SKILLS, & ABILITIES

1. Knowledge and ability to practically apply interpretations of laws, regulations, and standards regarding plasmapheresis, safety, and quality systems.

2. Ability to observe and analyze problems and issues in order to provide practical suggestions for process improvement.

3. Excellent diplomatic communication skills, verbal, and written. Interpersonal skills at organization, departmental, and individual levels.

4. Knowledge of technical or scientific aspects of some Plasma Center operational areas.

5. Knowledge of general computer operating principles. Capable of performing functions within word processing, spreadsheet, and database applications.

6. Ability to set priorities and handle multiple projects with conformance to deadlines.

7. Strong team member and team leader skills.

8. Strong ethical values.

9. Ability to maintain confidentiality.

10. Skilled in observation and detail-oriented.

11. Ability to observe practices, while comparing them to known requirements and report on disparities between actual and expected. Ability to analyze documentation for completeness, validity of information and compliance with applicable guidelines or regulations. Ability to analyze problems and issues in order to provide practical suggestions for process improvement.

12. Ability to make an audit a positive experience for all involved, without becoming personally involved in negative findings.

13. Ability to travel to other locations.

EDUCATION

Four-year (Bachelor's) Degree (BS) in Clinical/Medical Laboratory Sciences, Life Sciences or related field. Quality related Certification preferred.

EXPERIENCE

One to two years of experience related to plasma center operations, healthcare, quality system auditing or regulatory affairs in production of biologics, pharmaceuticals, or medical devices.

CERTIFICATES, LICENSES, ETC.

Clinical Laboratory Scientist License or be able to provide proof of eligibility to sit for the CLS/MLS licensing examination or Registered Nurse or equivalent credentials in a Quality related field preferred. Certification through a quality organization such as the American Society of Quality highly desired. Current Driver's License required.

PHYSICAL DEMANDS

Refer to ADA checklist attached for physical demands.

WORK ENVIRONMENT

Standard office conditions with minimal health and safety risks.

PlasmaShare is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

EEO is the Law. For more EEO information about applicant rights click here.

Our organization participates in E-Verify, for more information click here.

All applicants who receive a conditional offer of employment will be required to undergo a pre-employment drug test in accordance with PlasmaShare's established guidelines.