QA Supervisor

Company: ADMA Biologics, Inc.
Location: Boca Raton
Posted on: November 17, 2023

Job Description:

Job Details
Level: Management
Job Location: ADMA Biologics - Boca Raton, FL
Position Type: Full Time
Education Level: 4 Year Degree
Salary Range: Undisclosed
Job Category: QA - Quality Control

DescriptionADMA Biologicsis 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 thebiopharmaceutical industry that is committed toexcellence andintegrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Quality Assurance Supervisor in Boca Raton, FL!
The QA Supervisor oversees manufacturing operations to ensure compliance with cGMPs, GDPs, exception reporting and continuous improvement. Ensures daily MQA observations and other self-audit observations are properly documented, communicated, trended, and corrected appropriately to ensure continuous compliance with cGMPs, corporate policies, standards, and procedures.Qualifications

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  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.
  
  
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  Interact with Manufacturing (Fractionation/Purification/Fill Finish), Quality Control, Facilities/Engineering and other production support units to develop and implement corrective actions and process improvements.
  
  
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  Maintain a system for documenting observations daily MQA walkthroughs and other self-audit observations.
  
  
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  Ensure observations are properly documented, communicated to appropriate responsible departments, and corrective actions are timely executed.
  
  
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  Conduct trending of observations from daily quality audits, ensure appropriate corrective actions are initiated as adverse trends are identified, and communicate trending results to management.
  
  
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  Perform review of GMP documents (e.g. batch production records, batch testing records, etc.) to ensure compliance with GDPs, data integrity corporate policies, standards, and procedures.
  
  
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  Establish and maintain processes for real-time data review in Manufacturing.
  
  
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  Work with production personnel and other departments to resolve documentation and compliance issues.
  
  
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  Coach, mentor, and develop staff, including overseeing new-employee on-boarding.
  
  
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  Organize and present data/information on assigned projects to management.
  
  
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  Author and revise SOP, Work Instructions, Forms, as needed.
  
  
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  Coordinate and perform any additional activities or projects assigned by Quality Management.
  
  
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  Ensure timely escalation to senior management of any quality and compliance matters and/or deviations from the approved processes, policies/standards/procedures, discovered during the oversight of manufacturing operations and audits of other areas on site.
  
  
  Education Requirements:
  Bachelor's degree preferred 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:
  
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    401K plan with employer match and immediate vesting
    
    
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    Medical, Vision, Life and Dental Insurance
    
    
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    Pet Insurance
    
    
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    Company paid STD and LTD
    
    
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    Company Paid Holidays
    
    
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    3 Weeks Paid Time Off (within the first year)
    
    
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    Tuition Assistance (after the first year)
    
    
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    Easily accessible to Tri-Rail
    
    
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    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.
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Keywords: ADMA Biologics, Inc., Boca Raton , QA Supervisor, Other , Boca Raton, Florida