Quality Assurance Manager
3 weeks ago
A leader within the Medical Device industry is seeking an experienced Quality Assurance Manager to lead their site in the Buffalo area. This will be a temporary position lasting 6+ months.
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.
Oversee and manage the execution of quality systems
Establish, approve, and execute quality procedures to support commercial cGMP production
Lead the organization through internal and external audits and serve as the host for regulatory audits/inspections
Manage quality assurance personnel
Maintain KPI's and Quality Metrics at the site and present the data leadership
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 8+ years of experience in pharmaceutical or healthcare industry related experience, 3+ years of quality assurance management experience
Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations, and 21 CFR 210, 211, and 820.
Pay: $50-60/hr
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