Company: ADMA Biologics
Location: Boca Raton
Posted on: November 23, 2022
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.
- 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
- Support client and regulatory audits by US FDA and foreign
- Organize and present data/information on assigned projects to
- Manage investigations to support resolution of deviations
and/or process improvements.
- Lead and assist problem-solving and root-cause analysis
- 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
- 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
- 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
Keywords: ADMA Biologics, Boca Raton , QA Supervisor, Other , Boca Raton, Florida
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