KEDPLASMA is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and is currently licensed in 40 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.
1. Oversees Operational Compliance within the Donor Center
- Insures the compliance of all Center activities with Kedplasma DCOP's (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
- Directs details in special donor programs with assistance from Donor Center Director, e.g. titer testing and identification of pre-existing antibodies in new donors.
- Directs and supervises donor center employees to maintain quality assurance procedures.
- Trains employees to maintain daily center operations.
- Ensures that 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.
2. Manages Daily Center Operations
- 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.).
- Manages reception area (e.g., steady flow of production, special program monitoring documentation, donor center logs and record, etc.)
- Insures reception area, plasma room, and donor floor are well-stocked to handle current and next day's production.
- Maintains daily, weekly or monthly reporting documents (e.g., Donor Fees Reporting, Softgoods Inventory, Haemonetics Reports, PCS2 Logs and Event Tracking Logs, Payroll, Production reporting, etc.).
- Ensures daily completion of donor center logs and records (i.e., Final Weight sheets, Shipping Temperature Records, Quality Control Records).
- Ensures timely response to alarms and maintains alarm system.
3. Fiscal/Administrative Duties
- Works with Center Director to hire, train, and coordinate donor center staff members to ensure a competent, compliant, and quality team that yields production in accordance with company goals.
- Works with Center Director to prepare the team for volume increases, staff depletion, vacations, and absenteeism.
- Works with Center Director to maintain up-to-date personnel records (e.g., employee evaluations, training documentation, attendance, etc.).
- Works with Center Director to insure appropriate medical staff coverage or replacement (e.g., Center Physician, Physician Substitute, etc.) for donor center.
- Maintains center operations with fiscal responsibility in compliance with Good Manufacturing Practices (GMP), Quality Assurance Programs (QAP), and general housekeeping.
- Oversees reactive units' test results and completes unit disposition and paperwork follow through. This includes NAT Testing protocols and awareness of Viral Marker IQPP Stds.
- College degree strongly preferred or commensurate experience in customer service, conflict resolution, and employee supervision. Other combinations of education and experience may be considered.
- Ability to solve practical problems and deal with a variety of concrete variables.
- Must possess any licenses or certificates required by the state (e.g., including but not limited to CPR).
- Must be able to speak, read, write, and understand English.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedural manuals.
- Ability to read numbers on screening equipment (i.e., scales, thermometers, graphs, digital vital signs monitor, refractometer). Ability to write and record words and numbers legibly and accurately.
- Ability to operate computer software including DMS (with training) and Microsoft Office.
- Ability to sit or stand for extended periods for up to four (4) hours at a time.
- Ability to tug, lift, and pull up to fifty (50) pounds.
- Be able to bend, stoop or kneel and climb stairs or ladder.
- Occupational exposure to blood borne pathogens.
- While performing the duties of this job, the employee is regularly required to stand; use hands to, handle or feel objects, tools, or controls.
- The employee must be able enter a walk-in freezer at Center with a temperature of -30C and colder for short periods of time.
KEDPLASMA is a subsidiary of Kedrion Biopharma, a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.
Sun, 3 Sep 2017 13:47:59 PDT