Quality Assurance Manager

Job Description

Job Description

Type:

Contract/TEMP (6 months)
Location:

Buffalo, NY
Pay:

Up to $125,000
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.
Company Description Since 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.

Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.

Company Description

Since 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.\r\rAstrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
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