Location: Milford,MA, USA
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.