Quality Assurance Manager

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Management Glassboro, NJ, US

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.

• 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 rsee 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…