The Quality Technician will be responsible for the quality inspection processes, such as,comparing measurements, form, fit, function, and value judgments of simple and complex parts to blueprint specifications and general workmanship standards.
· Ensure Good Documentation Practices (GDP) are utilized throughout all quality records that are reviewed, completed, inspected, and audited.
· Coordination and performance of receiving, in-process and final inspection.
· Device History Record (DHR) reviews and batch release.
· Assist with event investigations, CAPA root cause analysis, deviations and change orders.
· Perform routine floor audits to ensure quality system and cGMP compliance.
· Participate in MRB and coordination of control of nonconforming products.
· Perform cleanroom environmental monitoring activities.
· Assist with in-house calibration activities.
· Acts as SME for inspection processes and train others.
· Participate in SOP creation and revision.
· Support continuous improvement projects.
· Oversight of quality inspection areas to ensure proper levels of 5S are maintained.
Saint-Gobain Life Sciences in Gaithersburg, Maryland is a state-of-the-art Life Science manufacturing facility. We produce cell culture bags, fluid transfer assemblies, single use assemblies and injection molded products in our ISO 7 and ISO 8 cleanrooms. We make a difference in the world by changing how we treat diseases through the manufacture of custom products used in cell and gene therapy clinical trials and manufacturing. We also support biopharmaceutical applications through the production of critical application final fill assemblies, molded components and other pharmaceutical applications.
· High school diploma or equivalent
· 3+ years of related experience preferred
· Must be able to read, write and understand English.
· Must be able to complete production paperwork and follow good documentation practice guidelines.
· Must be able to follow SOPs, observe safety procedures and report unsafe practices or situations to management.
· Strong organizational and communication skills, both written and verbal
· Must be able to work in a cleanroom environment.
· Must be able to effectively communicate to Quality leadership and site management about production issues.
· Strong ability to interpret an extensive variety of technical instructions, drawings or blueprints.
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.