Manager, Center Quality

Job Description Header:

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for an

Job Title: Manager, Center Quality

Job Description:

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.

Core Competencies/Behaviors:

• 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.

Compliance Requirements (ES):

• 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 and that

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In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.

Apply now