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Quality Assurance Specialist II, Manufacturing Quality Assurance (Fri - Mon) (Avecia: Milford, MA, Massachusetts, US) bei Nitto Denko Corporation

Nitto Denko Corporation · Milford, Vereinigte Staaten Von Amerika · Onsite

$67,900.00  -  $83,100.00

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About this opportunity :

 

The Quality Assurance Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are on-going daily. This is a first shift position (Fri-Mon) and comes with a 10% shift differential. 

 

Key Responsibilities:  

 

  • Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists.
  • Assist with production and QC to provide Good Manufacturing and Laboratory Practices.
  • Understand and execute MQA responsibilities that are defined in SOP.  
  • Monitoring manufacturing operations including cleaning by conducting reviews of logbooks.
  • Escalate detected major issues on the floor to MQA and QA management.
  • Review facility cleaning, material transfers and personnel hygiene control.
  • Providing quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance).
  • Based on outcomes of QMRs, quality council, internal and external audit findings, and QA operational (e.g., MQA) findings identify, propose and lead continuous improvement projects.
  • Provide Quality oversight and compliance guidance on new building program initiatives.
  • Train, motivate, monitor, and lead quality teams through necessary change. 
     
     

Required Skills/Abilities: 

 

  • At least 3 years’ experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
  • Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
  • Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
  • Problem-solving skills with the ability to adapt to changing priorities and timelines.
  • Ability to build positive working partnerships with other department teams.  
  • Experienced in the use of electronic systems such as eQMS.
  • Prior experience with clinical and commercial manufacturing is preferred.
  • Requires the ability to gown into clean rooms and wear PPE. 

 

The annualized salary range for this role is $67,900.00 - $83,100.00

Jetzt bewerben

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