Specialist, Quality Assurance

Overview

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. 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.

Specialist, Quality Assurance

• Assures the Plasma Center(s) is in compliance with all applicable state, federal, and European guidelines.
• Reports any deviations (cGMP) or regulatory practices to the Quality Director.
• Ensures SOPs, policies, and practices are updated and validated as applicable and that staff perform 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.
• Ensures accurate labeling and documentation of shipments.
• Maintains state of readiness for regulatory and customer audits.
• Tracks and trends errors, corrective actions, and approves preventative actions.
• Reports compliance status to necessary parties.
• Ensures accuracy of electronic donor records in the applicable donor center system.
• Ensures all supplies and materials meet quality regulations prior to placement into use.
• Monitors and ensures 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.

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

• Ability to follow the cGMPs and procedures with great attention to detail.
• Able to work in a high-pressure, deadline-driven environment.
• Basic computer skills including 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.
• Maintains competence with all position required tasks.
• Managing time.

• As part of our Quality Systems and cGMP initiatives, employees ensure compliance with all ADMA Quality policies, standards, and SOPs in their area of work and responsibility.
• This includes ensuring all QA records and reports, HR policies, and EHS procedures are completed in a timely manner.
• Any delay or failure to comply with policies, standards and procedures should be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EHS depending on the issue.

Note: Bachelor’s degree or equivalent professional experience and at least one year of QA experience in a related setting is preferred.

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.

ADMA 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 (Use the "Apply for this Job" box below). ADMA Biologics is an Equal Opportunity Employer.