QA Specialist II-Manufacturing Oversight

Location
Boca Raton, FL
Posted
Sep 21, 2020
Ref
22767
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 QA Specialist II-Manufacturing Oversight!

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:
  • Bachelors Degree preferred but can be offset by experience.

Experience Requirements:
  • 3-5 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.