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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.