QA Specialist Manufacturing Oversight

Company: ADMA Biologics
Location: Boca Raton
Posted on: June 23, 2022

Job Description:

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• Perform Quality Assurance review and approval of Deviation Reports.
  
  
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  • Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
    
    
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    • Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
      
      
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      • Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
        
        
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        • Review and release of Plasma pools to manufacturing.
          
          
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          • Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
            
            
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            • Review and release of raw materials in LIMS/SAP.
              
              
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              • Perform audits of Nitrogen receipt process.
                
                
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                • Perform notification and disposition of associated Lookback units.
                  
                  
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                  • Assist with quarantining and release of critical systems, equipment, and controlled environments.
                    
                    
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                    • Write, review, and revise QA SOPs.
                      
                      
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                      • Review SOPs and documents from other departments and provide feedback as necessary.
                        
                        
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                        • Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
                          
                          
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                          • Assist with training of new employees.
                            
                            
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                            • Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. - Required to work 12 hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). - Must be available to support coverage on either shift. Assist in other oversight activities, as needed
                              
                              
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                              • Coordinate and perform any additional activities or projects assigned by QA Management.
                                
                                
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                                • Experience with LIMS and SAP preferred.
                                  
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                                  - - - Education Requirements: - - - - - -
                                  
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                                  • Bachelors Degree preferred but can be offset by experience.
                                    
                                    - - - - Experience Requirements:
                                    
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                                    • -3-5 years experience in pharmaceutical or biotechnology industry or other related industry.
                                      
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                                      In addition to competitive compensation, we offer a comprehensive -benefits package including:
                                      
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                                      • 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
                                        
                                      • Company paid shuttle to the Boca Tri-Rail station
                                        
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                                        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.

Keywords: ADMA Biologics, Boca Raton , QA Specialist Manufacturing Oversight, Other , Boca Raton, Florida