About this opportunity :
The Quality Assurance 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 (Fri-Mon) and comes 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.
The annualized salary range for this role is $67,900.00 - $83,100.00