Head of Compliance Operations

Responsibilities

Maintain the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervise donor flow.

Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.

Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP.

Attend all required training sessions, staff meetings, etc. Ensures that accurate and thorough documentation of necessary records is performed.

Under the guidance of the Center Manager and/or the Assistant Manager, assure facility is maintained in a neat and clean condition and all equipment is kept in good working order.

Submit timely and accurate reports as required by the Center Manager and/or the Assistant Manager.

Assist in the control of center donor funds as determined by the Center Manager and/or the Assistant Manager.

Assist in the training of new employees and retraining of current employees.

Maintains active communication with other service areas to ensure accurate documentation and quality.

Builds rapport with donors to ensure overall customer satisfaction with the center to support long-term donation.

Reports all unsafe situations or conditions to area lead, supervisor or manager. May be trained to repair plasma center equipment. Assist the Center Manager and/or Assistant Manager in any task necessary in pursuit of company objectives.

Requirements

High school diploma or GED.

Certified as a Phlebotomist, Donor Processor, Plasma Processor, and Designated Trainer.

Typically requires 4 years of related experience with performing phlebotomy, donor processing, and plasma processing duties with demonstrated proficiency to handle difficult situations.

Hearing acuity essential.

Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye.

Certifications & Qualifications

Phlebotomist Certification

Donor Processor Certification

Plasma Processor Certification

Designated Trainer Certification

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