What are the responsibilities and job description for the Manager, Center Quality position at ADMA BioCenters?
Job Description
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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
Job Description Footer:
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
Apply now
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
Job Description Footer:
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