Job Description
Job Description
PURPOSE
Manages all operations related to the running of a center including supervising operations and ensuring
compliance with all applicable policy, procedures, and regulations. Assist the Director of Operations in achieving
operational goals and objectives on-time and on-budget while ensuring centers adhere to Standard Operating
Procedures, Current Good Manufacturing principles and Company policy.
General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices
and Company Policies. Ensure all facilities are in compliance with all applicable state, federal, consignees and
ABO designated regulations.
ESSENTIAL RESPONSIBILITIES & DUTIES
Project
• Proficient in software validation projects. Center NexLynk upgrades.
• Participate in new equipment validation.
• Assist in SOP revision for Operations.
• Obtain and maintain the ability to perform all tasks within the center as manager. Maintains annual
recertification of Center Manager training.
• May work as manager in donor center if required.
Regional Manager Duties
• Assist in the creation of an appropriate operations environment.
• Assist setting goals for centers with Center Manager and Director of Operations.
• Creates and monitors development plan for all Center Managers.
• Coordinate/collaborate in the hiring, training and evaluation of center management staff.
• Assist in budget preparation and review of required supplies for the center.
• Review and assist management team in scheduling and coordinating daily operations of the center.
• Assist in development and utilization of management team (Center Manager, Assistant Manager,
Training Specialist, QA Manager).
• Review documents for accuracy and perform documentation in a concise manner.
• Monitor staff for compliance and accuracy in processing donors at each visit.
• Perform facility inspections once a month at each center.
• Review schedules for in-service and safety classes to assure compliance with donor and staff safety
program.
• Assist in administrative actions of candidates and employees, up to and including, interviews of
potential employees, hiring, processing, evaluating, disciplining (including termination) of
employees as needed, to ensure centers are fully operational.
• Delegate or train all management team members as required.
• Monitor calibration and annual preventive maintenance of equipment.
• Monitor NexLynk issues are being opened and closed in a timely manner.
• Review monthly internal center area audits and give feedback and guidance.
• Review and monitor monthly center KPI’s via ADP.
• Review inventory counts to check for wastage of supplies.
• Monitor the checking of accuracy of packing units, preparation of documents, and shipment.
• Verify that all released plasma is being shipped out in a timely manner.
• Correspond with all testing laboratories in regards to test results as necessary.
• Review SOP monthly.
• Check center SOPs for accuracy of updates.
• Review all forms at center for current and updated forms.
• Attend inspections of centers. (FDA, consignee, etc.)
• Conduct inspections of center facilities every 2 months to include quality control, record
management, cleanliness of facility, and employee performance of duties.
• Manage center on a daily basis, as needed, when and if there is no Manager available.
• Verify and audit donor raffle documentation of center internal raffles.
• Monitor Donor Payment System for accuracy; ensure discrepancies are resolved. Review HAE daily
donor compensation reports.
• Assist in advertisement and recruitment of potential donors. Approve center monthly raffles and
review monthly marketing ads created by external vendor.
• Assist with donor or customer complaints, errors and accidents.
• Public Relations with outside organizations and community leaders.
• Maintain consistent communication with managerial team and/or Director of Operations to provide
all necessary information regarding the center or requested information from corporate office.
• Prepare weekly reports as need by corporate. Send weekly report on center production stats.
• Review payroll reports to keep overtime to a minimum. Review CM and AM timecards.
• Oversee all activities of assigned centers, including, but not limited to: interfacility relations,
ordering of supplies, shipping of product, accounting, advertising, equipment repairs and repairs to
facility or other duties as deemed necessary by Director of Operations.
• Plan and coordinate sending employees to other centers as needed for coverage.
• Must be able to balance competing priorities, ensure proper staffing levels, adequate levels of
plasma collection and adherence to quality standards.
• Must be able to control costs and maintain budget.
• Report Emergency Situations Immediately.
Other
• Maintain thorough familiarity and ensure compliance with state and federal regulations, U.S. Food and Drug
Administration (FDA), approved Standard Operating Procedures (SOP), Occupational Safety and Health
Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good
Manufacturing Practice (cGMP).
• Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook
and as otherwise posted or communicated.
REQUIREMENTS
• Bachelor’s degree with 1-2 years relevant work or 4-5 years relevant work experience required
• At least 3-5 years’ experience in management position or at least two years’ experience as a Center Manager
or equivalent position (equivalent position equals management experience in a regulatory industry)
• Previous experience should demonstrate expertise in cGMP’s, FDA regulations and SOP
implementation
• Must be able to show proof of High school diploma or equivalent or higher-level degree
• Proficient in English, bilingual skills (English/Spanish) – a plus
• Required travel up to 75%
• Must demonstrate excellent oral and written communication skills appropriate for all levels of an
organization
• Demonstrated Project Management Skills
• Ability to use standard office equipment
• Work well independently
• Excellent customer service skills
• Excellent team player and ability to work with others
• Computer skills including proficient in Microsoft Office
• Strong leadership abilities
PHYSICAL DEMANDS
Performing the responsibilities of the job requires ability to use hands and fingers to handle and feel objects,
tools or controls; reach with hands and arms. Frequently required to stand, walk, climb and balance; and stoop,
kneel, or crouch. Ability to read and review documents for up to eight (8) hours at a time and to stand for
extended periods of time (2-4 hours intervals). Ability to read, type while sitting in front of a computer up to 2
hours at a time. Physical ability to operate plasmapheresis machine and related equipment. Manual dexterity to
perform all phases of donor plasmapheresis that may require repetitive motions. Ability to lift, tug, and pull up
to 50 pounds.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such
as computers, phones, photocopiers, filing cabinets and fax machines. While performing the duties of this job,
the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is
usually quiet to moderate. Occupational exposure to blood borne pathogens. Personal Protective Equipment
required such as protective eyewear, garments and gloves. Work in a walk-in freezer for short intervals of time (-20C or colder).