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 I - Product Release in Boca Raton, FL!

The QA Specialist I - Product Release will have the primary responsibility consisting of the review of controlled documents for accuracy and completeness prior to Quality Assurance (QA) release of product.

Qualifications

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

• 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.

• Review and release manufacturing batch records, and any additional supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data.

• Perform usage decisions for batch release in SAP.

• Work with IgG Manufacturing floor personnel and other technical operation departments to resolve documentation and compliance issues.

• Perform period follow-up of ongoing deviations to assure timely closure of documentation and batch release.

• Review and approve Certificates of Analysis for batch release in LIMS.

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

• Perform review and release of Plasma pools when required.

• Initiate Deviations and Change Control as required.

• Review and revise QA SOPs.

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

Education Requirements:

• Bachelor's Degree required.

Experience Requirements:

• One to two years Quality Assurance (QA) experience in the pharmaceutical, biotechnology, or related industry. Experience with LIMS and SAP preferred.

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.