Group Lead Mfg Quality Assurance

Location
Boca Raton, FL
Posted
May 26, 2021
Ref
26102
Required Education
Bachelors 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 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.