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Specialist I QA- Product Release

Company: ADMA Biologics
Location: Boca Raton
Posted on: May 4, 2020

Job 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 Specialist I-Quality Assurance-Product Release The Specialist I-Quality Assurance-Product Release will Performs a wide variety of Quality Assurance activities to ensure compliance with related regulatory requirements. Main focus on review of batch records and associated documents for product release. Qualifications Responsibilities : Perform review and support release of manufacturing batch records (in-house and CMO batches) along with all manufacturing supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data. Perform review and release of all Plasma pools, both for internal use and shipment to customers as required. Perform real time review of batch records on the floor and manufacturing oversight, as required. Assist in failure investigations including support in the identification of root causes and corrective actions. Initiate, review and/or approve deviations, CAPAs, change controls, and any other site/product related documents as required. Review changes to SOPs and documents from other departments for accuracy and completeness. Assist on compiling data for Annual Prodyuct Quality Reports and metrics related to Quarterly System Review Board (QSRB). Review and release of raw materials in LIMS/SAP as needed. Identify, Initiate, and suggest quality/process improvements. 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. Coordinate and perform any additional activities or projects assigned by QA Management Education Requirements : Minimum of a BA or BS degree, preferably in the life or natural sciences. Experience Requirements: One to two years experience in pharmaceutical or biotechnology industry or other related industry. Other Essential Knowledge : Detail oriented, and has knowledge of scientific, medical and regulatory terms. Ability to use personal computer and software including word processing, spreadsheet and database. Demonstrated organizational and coordination skills, with close attention to detail and accuracy. Good inter- personal, written and oral communication skills. Demonstrated good problem solving skills with minimal supervision. Mathematical skills including the use of calculations involving fractions, decimals and percentages. In addition to competitive compensation, we offer a comprehensive benefits package including: 401K plan with employer match and immediate vesting Medical, Vision, Dental Insurance and Life 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 Shuttle to the Boca Tri-Rail station ADMA Biologics, Inc. 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.

Keywords: ADMA Biologics, Boca Raton , Specialist I QA- Product Release, Other , Boca Raton, Florida

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