Quality Assurance Manager

ABO HOLDINGS INC•Eagle Pass, TX

11h

About The Position

Ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training is consistent with the Company’s Standard Operating Procedure Manual (the “SOPs”), current State and Federal guidelines, OSHA, CLIA, cGMP, and any other internal Company procedures

Requirements

High School Diploma or Equivalent; Associates Degree (AA), preferred
One-year experience in a donor center with similar Quality Assurance or medical field experience or equivalent combination or education, training, and experience preferred
Must demonstrate excellent interpersonal, verbal, and written communication skills appropriate for all interactions with employees and donors.
Certified in Reception Area, Plasma Processing, and Donor Collection area (within 6-months of being assigned Quality Manager.
Must be able to work independently and multi-task effectively
Organized and have Computer skills including proficient in Microsoft Office
Demonstrate spreadsheet and database computer skills
Current CPR Card

Nice To Haves

Bilingual (English/Spanish), a plus
Travel as required

Responsibilities

Authorized to STOP PRODUCTION
Authorized to STOP RELEASE OF SHIPMENTS
Oversee all Quality Assurance functions at the collection center and ensure the center is audit-ready.
Work with Center Manager on schedule and approval of Paid Time Off (PTO).
Periodic or regular review, as needed, of center documentation such as donor records, logs, forms, test results, proficiency testing, and equipment validations/qualifications.
Report to the Center Manager any errors/incidents/events that may affect the safety, purity, identity, or quality of blood products.
Report to the Center Manager and oversee the handling of all product recalls and market withdrawals according to established procedures and guidelines.
Ensure that regular audits are performed at the center by Quality Assurance management. Audits of operations and procedures are performed to ensure compliance with all SOP, regulations, and internal Company procedures, including competency evaluations of all center personnel. Audits can be performed independently or at the request of center/corporate management.
Ensure all issues are reviewed and closed in a timely manner, with a maximum of 30 days provided for issues that require a lengthier investigation. If the 30-day timeframe cannot be achieved a notation should be in the issue as to why it cannot be achieved.
Oversee and review the equipment qualification process including receipt of new equipment, sending equipment out for repairs, qualifying new equipment, maintaining the equipment calibration calendar, and performing annual equipment calibrations when necessary.
Track and review trends of all incidents/issues, complaints, and Planned Deviations within the center.
Work with training to ensure all employee training is completed per Company’s SOP and other regulations.
Control the release/issue of soft goods and critical supplies. (FIFO)
Act as a point person for all external audits at the center. Oversee the Center Management/Quality Assurance Management response to external audit citations, including corporate audits of the center.
Ensure overall center compliance with all regulations/accreditations.
Ensure each employee/function in the center is provided with and had ongoing access to the necessary SOPs to perform assigned duties.
Perform lot release procedures of incoming soft goods and control of labels used on blood products
Maintaining NDDR access and data as a company manager
Reviewing all NDDR entries and notifications to state agencies regarding donors who have confirmed positive test results in accordance with SOP B 4.03 (External Agency Notification Regarding Permanently Deferred Donors).
In the event center management is absent from operations, Quality Assurance may submit donors into the NDDR so long as a secondary review from another qualified individual occurs. Quality Assurance is also responsible for reviewing issues related to NDDR corrections.
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.
Overseeing final release and shipment of product and samples.
React to all security and freezer alarms or concerns that occur on or off-hours.
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.