Specialist I - Supplier Quality Assurance

Employment Type

: Full-Time

Industry

: Information Technology



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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 Specialist I-Supplier QA!

The Specialist I-Supplier QA will perform a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements.

Qualifications

Responsibilities:

  • Assists with internal audits of all departments at the ADMA facility that are directly involved with activities described in the cGMPs cGMPs or have an impact on activities described in the cGMPs
  • Support in managing, receiving and coordinating the vendor notifications process.
  • Assists with the coordinaton and preparation of the Quality Systems Review Board (QSRB) process
  • Support in managing and cCoordinating Supplier Qualification Process
  • Processes product technical complaints
  • Process and coordinates supplier SCARS process
  • Process and coordinates monthly SQA (Supplier Quality Assurance) metrics
  • Resolves and negotiates issues as needed.
  • Coordinates projects as assigned by management.
  • Assists with coordination and scheduling of external supplier audits.
  • Ensures regulatory compliance as defined in government regulations CFR 210, 211, 600 and 820
  • Processes and reviews Distribution Reports, Audit Reports, Investigation Reports, and other controlled documents.
  • Discusses fundamental technical and regulatory issues as needed.

Education Requirements: Bachelors Degree required but can be offset by experience.

Experience Requirements: 1-3 years experience in pharmaceutical or biotechnology industry or other related industry.

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 and Personal Days
  • 3 Weeks Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Company paid shuttle to the Boca Tri-Rail station

ADMA Biologics, Inc. 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.



Job Requirements:

Associated topics: automation, performance test, process, quality assurance lead, software quality, software quality assurance, software quality engineer, software quality assurance engineer, test engineer, tester

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