QA Specialist I - Product Release - Adma Biomanufacturing Llc
Boca Raton, FL 33487
About the Job
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.