Specialist, Quality Assurance

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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 a Bio Center Quality Assurance Specialist.

Job Title:

Specialist, Quality Assurance

This position is responsible for ensuring all center activities are performed in accordance with standard operating procedures (SOPs) and the center is ready for inspection by regulatory agencies at any time.

• Key Duties (E)
  • Assures the Plasma Center(s) is in compliance with all applicable state, federal, and European guidelines.
  • Has the responsibility to report any deviations (cGMP) or regulatory practices to the Quality Director.
  • Assures that SOPs, policies, and practices are updated and validated as applicable and that staff is performing in accordance with SOPs through scheduled audits and direct performance observations.
  • 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 necessary parties.
  • 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 and competency training of existing staff on an annual basis.
  • Oversees execution, documentation, and review of internal and external audits.

• Ability to follow the cGMP’s and procedures with great attention to detail.
• Able to work in high‑pressure, deadline‑driven environment.
• Basic computer skills including experience with software programs such as Word, Excel, and Group Wise.
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
• Demonstrated ability to work well with people from diverse backgrounds.
• Exceptional organizational and communication skills required.
• Maintains competence with all position‑required tasks.
• Managing time effectively.

• Education Requirements:
  
  Bachelor’s degree or equivalent professional experience.
• Experience Requirements:
  One minimum of one year of Quality Assurance experience in a Donor Center or similar Quality Assurance or medical field experience.

Experience in a cGMP environment and familiarity with QA systems and documentation.

• Ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility.
• Ensuring all QA records and reports, HR policies, and EH&S procedures and practices are completed in a timely manner.
• Escalating any delay or failure to comply with policies, standards and procedures to the appropriate responsible parties.

• 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, including free shuttle to the Boca Tri‑Rail station.

ADMA Biologics is an Equal Opportunity Employer.