Job DetailsLevel ManagementJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Shift DayJob Category QA - Quality ControlDescription
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