QA Specialist II-Manufacturing Oversight

Company: ADMA Biologics
Location: Boca Raton
Posted on: January 12, 2021

Job Description:

). 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.

Keywords: ADMA Biologics, Boca Raton , QA Specialist II-Manufacturing Oversight, Other , Boca Raton, Florida