Plasma Center Quality Manager (27994)

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.

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

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

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

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.

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.

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

in external audits. When possible Quality Manager will host 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.

proficiency with and apply process improvement tools.

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

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

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

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.

in oversight of Information Services and Change Management.

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.

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

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 customers 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 employees 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

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

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

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

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

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

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

team member and team leader skills.

ethical values.

to maintain confidentiality.

in observation and detail-oriented.

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.

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 (Bachelors) 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 Drivers 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 PlasmaShares established guidelines.