QA Supervisor

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

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 Quality Assurance Supervisor! The QA Supervisor oversees a team of Quality Associates, Engineers and/or technical writers to support the manufacturing operation compliance with cGMPs, exception reporting and continuous improvement. Qualifications

• 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, standards, and procedures.
  • Oversee group of Manufacturing Quality Associates providing direct QA oversight of GMP Manufacturing Facility.
    • Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance development planning.
      • Coaches, mentors and develops staff, including overseeing new-employee on-boarding and providing career development planning and training opportunities.
        • Evaluate the impact of deviations and adverse events to product quality and provide detailed product impact analysis in collaboration with subject matter experts.
          • Interact with Manufacturing, Engineering and Technical Operations units to develop and implement corrective actions and process improvements.
            • Support client and regulatory audits by US FDA and foreign regulatory bodies
              • Organize and present data/information on assigned projects to upper management.
                • Manage investigations to support resolution of deviations and/or process improvements.
                  • Lead and assist problem-solving and root-cause analysis sessions.
                    • Perform quality review of GMP documents, as needed.
                      • Author and revise GMP documents, as needed.
                        • Work with IgG Manufacturing floor personnel and other technical operation departments to resolve documentation and compliance issues.
                          • Assist with new employee and on-going cGMP training, as needed.
                            • Coordinate and perform any additional activities or projects assigned by Quality Management. Education Requirements: Bachelor's degree required but can be offset by experience. Experience Requirements: Three to five 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
                              • Free 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 . ADMA Biologics is an Equal Opportunity Employer

Keywords: ADMA Biologics, Boca Raton , QA Supervisor, Other , Boca Raton, Florida