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QA Specialist Manufacturing Oversight

Company: ADMA Biologics
Location: Boca Raton
Posted on: June 23, 2022

Job Description:

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  • 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 Manufacturing Oversight, Other , Boca Raton, Florida

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