Center Medical Director Back Up - CONTRACTOR

Please note:

This is a contract position and is a backup to the Center Medical Director.

JOB SUMMARY

Responsible for donor safety and welfare through donor history and physical examinations, informed consents, management of donor reactions, evaluation of laboratory results and immunizations. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. Additionally, responsible for providing independent medical judgment and discretion for issues relating to donor safety, health, and suitability for plasmapheresis and/or immunization relating to the Clinical Laboratory Improvement Amendments of 1988 ('CLIA') non-waived laboratory testing at the donor. Supports optimum delivery of services as an ethical and high-quality provider of plasma. Upholds KEDRION values while leading plasma collection center employees by ensuring strategies meet professional standards through policies and procedures, and Federal, State, and local, guidelines and/or regulations.

ESSENTIAL JOB FUNCTIONS

Every effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.

MAIN DUTIES AND RESPONSIBILITIES

Core

• Observes and approves Physician Substitute initial and/or annual recertification. Additionally, reviews the initial, at 6 - months and annual employee training for the performance of CLIA designated moderate complexity tests, using independent medical judgment to evaluate training and performance.

• Reviews the donor's accumulated laboratory data and collection records as required in 21 CFR 640. 65 to determine the donor's continued suitability.

• Reviews and approves abnormal SPE/RPR Test Profiles and reviews all other abnormal laboratory test results on a weekly basis.

• Determines the status of donor suitability for donors with abnormal laboratory test results.

• Reviews 10% of the weekly SPE/RPR Test Profiles completed by each Physician Substitute for the Medical Review as required.

• Complies with all facility SOPs, FDA and EU regulations, OSHA, PPTA, CLIA and COLA requirements and properly documents said compliance.

• Makes sure that a Physician is present int the premises while donor red cell immunization procedures are being performed.

• Determines donor suitability when screening values fall into the borderline areas (e. g. , elevated blood pressure, elevated pulse, weight loss) when applicable.

• Refers donors to other medical facilities or physicians as necessary (e. g. , donors with infectious disease markers such as Anti-HCV, Anti-HIV 1/2, HBsAg, HIV-1 NAT or HCV NAT reactive test results) and serves as a liaison between the plasmapheresis facility and such medical facilities and physicians.

• Assures donor satisfaction through appropriate physician interaction and responsiveness to donor needs when needed.

• Observes staff, center activity, and practices, and communicates compliance issues to appropriate individuals when needed.

• Proposes revisions to SOPs and Company practices when appropriate.

• Reviews and approves the CLIA defined moderate complexity test procedures.

• Selects suitable plasmapheresis donors pursuant to the Physician's medical education and experience and in accordance with SOP, FDA, PPTA, OSHA, CLIA, cGMP by utilizing informed consent administration, assessing medical history, and administering physical examinations if applicable.

• Explains informed consents for plasmapheresis and immunization to donors based upon the Physician's judgment and discretion and in compliance with 21 CFR 630. 5 including but not limited to explanation of the plasmapheresis procedure, hazards, potential adverse reactions, and specific immunization programs if applicable.

• Answers and discusses any donor questions and ensures the donor is given a clear opportunity to refuse participation when needed.

• Provides appropriate level of care and medical judgment when assessing issues related to unusual or severe donor reactions if applicable.

• Exercises medical judgment by assessing donor situations and institutes appropriate management procedures in accordance with current SOP and the center's standing orders.

• Administers and/or supervises administration of immunizations, order immunizations, and utilizes medical expertise to analyze candidates and/or donor's reactions if applicable.

• Reviews the QC/QA/proficiency testing reports for timely and appropriate actions on moderate complexity procedures for test problems.

• Assures on-call availability to provide consultation on donor suitability and medical emergencies when needed.

Managerial / Supervisory

• Manages and oversees direct reports.

• Disciplines and terminates employees following approved company guidelines.

• Establishes and communicates performance standards to meet or exceed standards.

• Coaches others for success and to meet established goals and/or standards.

• Recruits, interviews, hires, and trains employees, as needed.

• Oversees work assignments to include supporting and rearranging workload of direct reports.

• Provides constructive and timely performance evaluations including motivating and evaluating employees based on established performance standards.

• Promotes staff retention by creating an open, positive, and supportive work environment.

• Receives, investigates, and responds to employee grievances. Involves and obtains guidance from supervisor and human resources when needed

General

Must be able to execute all terms and conditions set forth in the KEDPLASMAEmployeeHandbook , including, but not limited to:

• Work in a safety-conscious manner which ensures that safe work practices are used in order not to pose a risk to self or others in the workplace.

• Comply with company Global Code of Conduct and company's policies and procedures and all the applicable regulations.

• Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene, and dress code.

• Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as instructed by supervisor/manager.

• Cooperate with department personnel, as well as other center staff to ensure services can be adequately maintained to meet the needs of the donors.

• Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas and/or improving services.

• Complete all assigned tasks in a timely man.