Manager, Center Quality

Job Title:

Manager, Center Quality

• Assures the Donor Center(s) complies with all applicable state, federal, and European Union guidelines.
• Direct responsibility for the day-to-day activities, evaluation, and training of the Quality Assurance Specialist.
• Authorizes the release of final product and has the authority to stop shipment of any product that does not meet compliance or customer specifications.
• Assures accurate labeling and documentation of shipments.
• Assures center maintains state of readiness for regulatory and customer audits.
• Responsible for tracking and trending errors, corrective actions, and the approval of preventative action.
• Reports compliance status to Center Management and Regional Quality Assurance Manager routinely.
• Assures accuracy of electronic donor records in the applicable donor center system.
• Assures all supplies and materials meet quality regulations prior to placement into use.
• Monitors and ensures the maintenance and calibration of equipment is completed and documented as required by procedures.
• Ensures completion and accuracy of training for new employees, competency training of existing staff on an annual basis, and training records.
• Maintains competence with all position required tasks.
• Maintains the center compliance monitoring system to assist in the identification of risk areas.
• Attends and actively participates in Plan, Do, Check, Action meetings.

• Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs.
• Oversees execution, documentation, and review of internal and external audits.
• Actively provides feedback to operations management and staff regarding staff performance against SOPs. Works to develop and maintain a collaborative and effective working relationship with operations management.
• Responsible for ensuring the center meets all regulatory and quality timelines as established in SOP documents.

• Has the responsibility to report any deviations (GMP) or regulatory practices to the Regional Quality Assurance Manager.
• Assures that SOPs, policies, and practices are updated and validated as applicable.

In addition to competitive compensation, we offer a comprehensive benefits package including: 401K plan with employer match and immediate vesting, Medical, Vision, Life and Dental Insurance, Pet Insurance, Company paid STD and LTD, Company Paid Holidays, 3 Weeks’ Paid Time Off (within the first year), Tuition Assistance (after the first year), Easily accessible to Tri-Rail, Free shuttle to the Boca Tri-Rail station.

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ADMA Biologics is an Equal Opportunity Employer.