Job Description

JOB SUMMARY: Assists and supports the Center Manager in the daily operations of a plasma collection center. Supports Center Manager in all aspects of center performance, including quality and compliance, operations, and financial aspects including strategies and assures the company image as an ethical and high-quality provider of plasma is developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR.

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: Ensures the compliance of all plasma collection center’s activities with KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required. Maintains plasma collection center’s operations with fiscal responsibility in compliance with current Good Manufacturing Practices (cGMP), Quality Assurance Programs (QAP), and general housekeeping. Directs details in special donor programs with assistance from Center Manager, e.g. titer testing and identification of pre-existing antibodies in new donors. Collaborates with the management team to ensure the plasma collection center is appropriately staffed to effectively manage current and anticipated future donation volumes. Works with Center Manager to maintain up-to-date personnel records (e.g., employee evaluations, training documentation, attendance, etc.). Works with Center Manager to ensure appropriate medical staff coverage or replacement (e.g., Center Physician, Physician Substitute, etc.) for plasma collection center. Works with Center Manager to prepare the team for volume increases, staff depletions, vacations, and absenteeism. Ensures professional customer service skills, courtesy, and respect are utilized by center staff to maximize donor retention. Identifies all potential, serious, or chronic problems affecting quality or compliance. Ensures daily completion of plasma collection center logs and records (i.e., Final Weight sheets, Shipping Temperature Records, Quality Control Records). Ensures stock is adequate to support current production in all applicable areas. Maintains daily, weekly, or monthly reporting documents (e.g., Donor Fees Reporting, Softgoods Inventory, Haemonetics Reports, and Event Tracking Logs, Payroll, Production reporting, etc.). Manages all equipment in the plasma collection center to ensure adherence to the required maintenance schedule, and the timely removal and return to service of malfunctioning or otherwise non-compliant equipment. Responds to freezer alarms and resolves freezer excursions, minimizing risk to product quality. May participate in performing tasks associated with deviation management, including documenting quality events, conducting investigations, and identifying and implementing plasma collection center corrective and preventative actions (CAPA). Performs opening and closing duties (e.g., powering on/off equipment, documents petty funds and donor fund disbursement, locking up monies and files, maintains alarm system, etc.).