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Responsible to provide Process/Quality Engineering support to manufacturing
Provide Direction in areas of Design Controls & Risk Management for new product line
Our client is a bioprocessing-focused life sciences company.
- Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectations (e.g., Quality System Regulation, ISO standards, ASME BPE, etc.). Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and 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 product development team members.
- Leads 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)..
- Support the suATF product line through the review of batch records and lot release.
- Additional responsibilities involve review of supporting data for production activities, such as, environmental monitoring, Reverse Osmosis Deionized water, cleaning logs, and controlled temperature chamber logs. This individual will also assume various administrative functions, such as, label generation, binding, and filing of production records
- Perform batch record review; to include production, monthly RO/DI, weekly Environmental Monitoring records, and weekly/monthly logs
- Identification of process deviations, corrective actions
- Identify out of trends and out of specifications for product
- Verify labels generated by Document Control
- Bind and file completed batch records
- Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
- At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).
- Understanding of basic chromatography, fermentation and purification (production and lab scale) is required for this position
- Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
- Minimum 5-7 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent
Rapidly growing company, with internal room for growth at a stable company.