QA Specialist II, Manufacturing Quality Assurance

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.