- Quality Assurance
- Certified Quality Engineer
- ISO 9001
- ASME Codes & Standards
Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide.
Essential Duties and Responsibilities:
The successful candidate will be responsible to provide Process/Quality Engineering support for new product development and manufacturing support for commercial products, working to ensure the development and supply of high-quality products to our customers.
Provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Product line support will focus on plastic and stainless-steel devices and associated consumables used for cell culture, filtration and chromatography products.
Serve as a Subject Matter Expert for application of Design Controls in accordance with regulatory expectations (e.g., Quality System Regulation, ISO standards, ASME BPE, CE, BPOG etc.). Ensures the comprehensive completion of risk management, Design Verification, and Process/Design Validation activities for products and processes. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other multi-functional product development team members.
Lead the effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Ensure the development and validation of appropriate test methods for product and process performance
Ensure active and thorough investigation of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints).
Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results Education and/or Work Experience Requirements: At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science requires).
Experience with stainless steel and plastic device or consumable products and associated manufacturing processes.
Understanding of the basics of cell culture and filtration and chromatography operations in a bioprocess setting is required for this position
Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
Minimum of 5-7 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent