• Job Description

  Req#: 71754

  Job Details

  Job Location: ADMA Biologics - Boca Raton, FL

  Position Type: Full Time

  Salary Range: Undisclosed

  Job Shift: Nights

  Job Category: Pharmaceutical

  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-Manufacturing Oversight in Boca Raton, FL!

  The QA Specialist II-Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

  Qualifications

  
  

  • Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).

  • Perform Quality Assurance review and approval of Deviation Reports.

  • Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.

  • Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.

  • Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.

  • Review and release of Plasma pools to manufacturing.

  • Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)

  • Review and release of raw materials in LIMS/SAP.

  • Perform audits of Nitrogen receipt process.

  • Perform notification and disposition of associated Lookback units.

  • Assist with quarantining and release of critical systems, equipment, and controlled environments.

  • Write, review, and revise QA SOPs.

  • Review SOPs and documents from other departments and provide feedback as necessary.

  • Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.

  • Assist with training of new employees.

  • Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12 hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift. Assist in other oversight activities, as needed

  • Coordinate and perform any additional activities or projects assigned by QA Management.

  • Experience with LIMS and SAP preferred.

  Education Requirements:

  • Bachelor's Degree preferred but can be offset by experience.

  Experience Requirements:

  • 3-5 years of experience in pharmaceutical, biotechnology, or other related industries.

  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.

• About the company

  ADMA Biologics, Inc. is a late-stage biopharmaceutical company that develops, manufactures and intends to market specialty plasma-based biologics for the treatment and prevention of infectious diseases. The Company is engaged in the development and com...

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