Quality Assurance Manager

Quality Assurance

Buffalo, NY, US
Pay Rate Low: 50.00 | Pay Rate High: 60.00

Responsibilities:

Serve as the site lead of quality assurance and the management representative of large scale manufacturing site.
Manage, maintain, and continuously improve the quality management system at the site level.
Provide site quality leadership to quality systems maintenance, raw material and final product release, supply & automation, manufacturing, validation, product quality complaints, deviations, corrective and preventative actions (CAPAs), and facility engineering.
Establish, approve, and execute quality procedures to support commercial cGMP production
Oversee and manage the execution of quality systems during daily production activities
Lead the preparation and execution of both internal and external audits and serve as the host for regulatory audits/inspections
Maintain KPI's and Quality Metrics at the site and present the data to Operations and Senior Quality Leadership on a monthly basis.
Manage quality assurance personnel and when necessary, recruit, train, and develop quality assurance personnel to meet applicable cGMP compliance requirements and business objectives.
Manage vendors for any outsourced activities and suppliers for the site and audit the vendors and suppliers as required.

Qualifications:

Bachelor’s degree in a health or science field required; Advanced degree preferred.
Minimum of 5+ years of experience in pharmaceutical or healthcare industry related experience, 3-5 years of quality assurance management experience
Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations and guidance, and 21 CFR 210, 211, and 820.

INDBH

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