The Quality Technician supports commercial production activities and provides routine quality oversight of production processes to ensure product quality and adherence to procedural requirements. The Quality Specialist ensures real-time assessment of, and initiates problem solving for, nonconformities and other quality related issues, including approval of correction and containment actions. This position has the responsibility and authority to escalate unsatisfactory production processes and identify nonconforming product based on established criteria.
· Review and release of incoming raw materials
· In-process and final product dimensional /attribute inspections and testing
· Verification of line clearance
· Identification/segregation on nonconforming product
· Coordination/approval of correction and containment actions
· Review of production records for accuracy of completeness, product release and CoC generation
· Calibration/maintenance oversight
· Review/approval of changes and controlled documents
· Support oversight of product realization activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification, and materials management.
· Assist in the development and maintenance of quality systems related to inspection, testing, nonconforming product, calibration, and maintenance.
· Support of ISO certification, customer quality issues, and continuous improvement
· Customer audit support
· Assist in complaint investigations
· Conduct internal audits and assist in CAPA development
· May be assigned to implement CAPAs and conduct training
· Bachelors or Associates Degree and two (2) years related experience (QA or QC) in a regulated environment; In lieu of a degree, five (5) years of related experience (QA or QC) in a regulated industry will be considered. (Preferrred)
· Excellent analytical / problem solving and interpersonal skills required.
· Knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required.
· Must work well in a team environment, possess an ability to adapt to change in the environment, be task oriented, and work without direct supervision.
· Proficient computer skills required, including Microsoft Word and Excel
Who are we ?
Saint-Gobain’s innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world’s leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life’s critical moments.
Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we’ve learned working together makes good ideas, great ones.
With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths.
Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you’re empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.
Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.