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QA Specialist II, Manufacturing Quality Assurance

QA Specialist II, Manufacturing Quality Assurance

Nitto DenkoCincinnati, OH, United States
4 days ago
Job type
  • Full-time
Job description

About this opportunity :

The QA 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 (Mon-Fri).

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.