QA Specialist II - Quality, Engineering, Validation
Job Details
ADMA Biologics - Boca Raton, FL
Full Time
Description

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 QA Specialist II-Quality, Engineering, Validation!

The QA Specialist II-Quality, Engineering, Validation will Perform a wide variety of Quality Assurance activities to ensure compliance with related regulatory requirements.  Primarily responsible for the efficacy and compliance of the change control management system, validation and qualification systems, Corrective and Preventive Action reports (CAPA) and Risk Management policies and procedures.

Qualifications
  • Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures.
  • Perform QA review and approval of Change Control and Corrective Action Preventive Action (CAPA) Quality Systems.  Independently assess required supporting documentation to support change and corrective/preventive actions.
  • Assist in the Change Review Board (CRB) to ensure that changes are initiated, evaluated, properly classified, authorized and implemented in accordance with Regulatory and Corporate requirements.
  • Perform QA review and approval of Equipment, Process, Automation, PD, IT, QC, AD, Cleaning and Stability Validation protocols and reports.
  • Work closely with Validation team and provide support to ensure documentation is accurate and complete.
  • Utilize Quality Risk Management to identify, assess, control and review any potential impact to process, product or equipment.  Assist in quality improvement plans.
  • Assist with internal, customer and regulatory audits.
  • Perform QA review and approval of additional documentation and Quality Systems such as SOPs, Forms, Reports, Deviation, etc. as needed.
  • Discuss fundamental technical and regulatory issues, as well as resolve and negotiate quality related issues, as needed.
  • Assist with new employee and on-going cGMP and quality related training as required.
  • Coordinate and perform any additional activities or projects assigned by QA Management.

 

Education Requirements:             Bachelors Degree.

Experience Requirements:           1-5 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
  • 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 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.

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