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