Engineer-Quality Assurance

Location
Boca Raton, FL
Posted
Jan 13, 2021
Ref
24396
Required Education
Bachelors Degree
Position Type
Full time
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 Quality Assurance Engineer!

The Quality Assurance Engineer leads and implements processes to ensure continuous quality improvements , and compliance of our processes.

Qualifications

  • Ensure current Good Manufacturing Practice (cGMP) and regulatory compliance as defined in government regulations including but not limited to 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate polices and procedures.
  • Execute and help optimize the Quality Management System (QMS).
  • Lead or participate in initiatives to improve quality systems for any potential compliance gaps or trends in product quality.
  • Develop,report, and analyze data and metrics and implement recommended actions to address adverse quality trends or compliance gaps.
  • Lead cross-functional teams to resolve investigations using Root Cause Analysis tools.
  • Lead cross-functional teams to conduct quality risk analysis, as needed, to identify root causes for process and system failures, and analyze changes under consideration.
  • Assist departments to identify gaps in processes and systems to improve product quality and process efficiency and effectiveness.
  • Assist, participate and/or coordinates document revisions as needed for the department.
  • Able to manage, write, and evaluate deviations, change controls, and CAPAs. Work closely with employees at multiple levels within the organization in order to achieve timely completion of quality systems records ( Deviations, CAPAs, Change Controls ) .
  • Ensures CAPAs are effective and implemented according to schedule.
  • Review and/or provide quality impact assessments for quality system records, as needed.
  • May lead internal and external quality audits, Organize and support Quality Review Board (QRB) meetings and Quarterly System Review Board (QSRB) meetings.
  • Able to assemble and author product APQRs (Annual Product Quality Review)

Education Requirements: Bachelor of Science degree in a scientific field, preferably microbiology, chemistry, or engineering. LSSGB/CQE certification required, LSSBB certification preferred. .

Experience Requirements: Minimum of 5-7 years experience in Manufacturing or Quality Assurance in an FDA regulated environment. Experienced facilitator and leader of LSSGB/BB and Kaizen projects with verified ROI in terms of compliance, cost, effectiveness, or efficiency. Demonstrated ability to lead in depth root cause analysis teams. Facilitation of quality risk management in a pharmaceutical environment.

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 www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.