Quality Assurance Manager

PURPOSE

Ensure all center operations, product storage, documentation, facility maintenance, quality control, and training are consistent with the Company's Standard Operating Procedure Manual (the "SOPs"), current State and Federal guidelines, OSHA, CLIA, cGMP, PPTA and any other internal Company procedures

General Requirements - Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices and Company Policies.

ESSENTIAL RESPONSIBILITIES & DUTIES

Authorized to STOP PRODUCTION

Authorized to STOP RELEASE OF SHIPMENTS

• Oversee all Quality Assurance functions at the collection center and ensure center is audit ready.
• Provide direct supervision of Quality personnel, including coordinating Quality staff schedules, reviewing and approving Quality staff timecards in the payroll system (ADP), approving Paid Time Off (PTO) requests, and ensuring adequate Quality coverage to support compliant center operations
• Monitor and report Quality KPIs in accordance with corporate requirements
• Assist in the interviewing and hiring of new quality coordinator(s) for the center.
• Oversee and train new quality staff members as needed.
• 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.
• Plan, conduct, or oversee internal quality audits and ensure corrective and preventive actions (CAPAs) are implemented and verified for effectiveness.
• Ensure quality investigations, deviations, complaints, and CAPAs are completed within established timelines. Investigations exceeding 30 days shall include documented justification.
• 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.
• Analyze and trend deviations, complaints, CAPAs, audit findings, laboratory discrepancies, and other quality indicators to identify systemic issues and recommend continuous improvement initiatives.
• Review BPDRs and lookback for accuracy and ensure their timely submission.
• Work with training to ensure all employee training is completed per Company's SOP and other regulations.
• Control the release/issue of softgoods and critical supplies. (FIFO)
• Act as a point person for all external audits at 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

o 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.

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
• Bilingual (English/Spanish), a plus
• Minimal travel required

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. Ability to read and review while sitting in front of a computer for up to 8-hours at a time and to stand for extended period of time (2-4 hour intervals.) Ability to read, type while sitting in front of a computer for up to 2 hours at a time. Physically able to operate equipment plasmapheresis machine and related equipment. Manual dexterity to perform all phases of donor 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. While performing the duties of the 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 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).