- ADMA Biologics
- Boca Raton, FL
- Start date
- Mar 9, 2023
- Quality, Quality Assurance
- Required Education
- Associate Degree
- Position Type
- Full time
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 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 www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer
ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
5800 Park of Commerce Blvd. NW
Boca Raton, FL 33487
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