Specialist, Quality Assurance

ADMA Biologics

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 Bio Center Quality Assurance Specialist.

This position is responsible to ensure 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. The Quality Assurance Specialist (QAS) assists in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed in an effort to reduce or eliminate the potential of errors.

This may be identified through scheduled audits, performance observations, or record review.

This position assists in the gathering and compilation of data and information to provide appropriate monitoring of all quality initiatives and programs. The QAS is responsible for ensuring an appropriate investigation of any deviations from process or procedure is complete, which may require root cause analysis and effective corrective or preventative actions. Monitoring for the recurrence or the potential for recurrence is a critical component of data analysis.

• 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.

• 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.

• As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility.
• This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety…