QA Supervisor

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.

 

 

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 www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer