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.