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 position works a 4-10 hour shifts (Friday - Monday) 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.