What are the responsibilities and job description for the Assistant Center Manager position at ABO HOLDINGS, Inc.?
PURPOSE
The Assistant Manager will perform under the supervision of the Center Manager, and at times will take instruction and tasks from the Quality Assurance Manager.
General Requirements - Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, and Company Policies. Ensure the facility is in compliance with all applicable state, federal, consignees, and ABO designated regulations. Ensure donor suitability, product integrity, and continued good health of donors through the center's compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company, and any other applicable regulatory standards.
ESSENTIAL RESPONSIBILITIES & DUTIES
- Assist Center Manager in ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training is current and consistent with the Company's Standard Operating Procedures Manual (the "SOP"), current State and Federal guidelines, OSHA, CLIA, cGMP, and any other internal Company procedures.
- Regular review and updating, as needed, of center documentation such as logs, forms, proficiency testing, equipment validations / qualifications, and other records to ensure compliance.
- Assist in managing the center's donor flow and on-site personnel, including scheduling, managing break times, and responding to day-to-day issues and concerns; elevate issues when necessary.
- Oversee some employee training (particularly in phlebotomy training) of the Company's SOP and other regulations, and perform some 6-month and annual observational assessments of all employees with a written report of same.
- Report to Quality Assurance any errors / incidents / events that may affect the safety, purity, identity, or quality of blood products.
- Assist in reviewing, investigating, and responding to all issues, donor complaints, employee concerns, post-donation information, etc.
- Assist center management in quarantining flagged or unacceptable units.
- Maintaining NDDR access and data as a company manager.
- Submitting donors into the NDDR and notifying state agencies about donors who have confirmed positive test results in accordance with SOP B 4.03 (External Agency Notification Regarding Permanently Deferred Donors).
- In the event quality assurance is absent from operations, Center Management may review NDDR entries so long as the initial submission is made by a qualified different individual. Center Management is also responsible for resolving any error corrections to the NDDR if data errors are discovered.
- Abiding by the signed management confidentiality agreement, and ensuring that records and data printed from the NDDR are kept in a confidential area of the center or destroyed by shredding these printed records.
- Assist with product shipments.
- Ensure center is regularly clean, safe, and organized; report maintenance, facilities, and equipment concerns or issues
- Fill in and assist with center operations, when needed.
- Perform some duties of the Center Manager in the Center Manager's absence, or as directed.
- Adhere to all company policies, procedures, and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.
- Any other duties as assigned.
REQUIREMENTS
PHYSICAL DEMANDS
Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with the hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer for up to 4-hours at a time. Physically able to use and operate equipment used in assessing donor suitability as well as equipment used to harvest plasma. Manual dexterity to perform all phases of plasmapheresis. 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. May be exposed to bloodborne pathogens and other conditions common to a donor center. Personal protective equipment required such as eyewear, lab coats, and gloves. May work in a walk-in freezer for short intervals of time (-20C or colder).
