Group Lead Mfg Quality Assurance
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 Group Lead in Manufacturing Quality Assurance!
The Group Lead will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.) and resolution of issues on the manufacturing floor.Qualifications
- Possess an understanding of cGMP and regulatory compliance as defined in government regulations 21 CFR 11, 210, 211 and 600.
- Evaluate the impact of deviations and adverse events to product quality and provide detailed product impact analysis in collaboration with subject matter experts (SME’s).
- Work with other departments to assess and determine if the need for a Deviation, Event, CAPA and Change Control is required.
- Work with manufacturing floor personnel and other technical operation departments to resolve documentation and compliance issues.
- Coach, mentor and develop Quality Assurance staff, including new-employee on boarding and routine training.
- Assist Q.A. Supervisor setting performance standards and encourage employee engagement through delegation, continuous feedback, goal setting and performance development planning.
- Assist Q.A. Supervisor with management of investigations to support resolution of deviations and/or process improvements.
- Interact with Manufacturing, Engineering and technical units to develop and implement CAPA’s.
- Possess an understanding of Quality Systems (e.g. Deviations, Events, CAPA, Change Control).
- Lead and assist problem-solving and root cause analysis sessions.
- Oversee and/or perform oversight and inspections of active production to ensure compliance with Standard Operating Procedures (SOP’s).
- Perform oversight activities of all pertinent areas.
- Review manufacturing support documentation (logbooks, log sheets and charts).
- Review and release of plasma poolls to manufacturing.
- Perform review and release of raw materials
- Perform scheduled audits of Nitrogen receipt process.Assist with the quarantine and release of critical systems, equipment and controlled environments.
- Perform quality review of cGMP documents, as required.
- Write, revise and review Quality Assurance Standard Operating Procedures (SOP’s).
- Support client audits and regulatory inspections performed by the U.S. Food and Drug Administration and foreign regulatory bodies.
- Organize and present data/information on assigned projects to upper management.
Education Requirements: Bachelors degree in Engineering or Science related field desired. Degree can be offset by experience.
Experience Requirements: Five (5) to ten (10) years experience in the pharmaceutical, biotechnology 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, Dental Insurance, Life and Disability
- 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
- 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.