Quality Engineer (Cell Culture)
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Kennebunk, ME 04043
Quality Engineer (Cell Culture)
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Date: Nov 21, 2019
Location: Kennebunk, ME, US, 04043
Requisition Number: 38506
Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise inspecialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives.
Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.
As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.
Scope of Position:
This position involves cell culture product support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement and Business Operations) and is responsible for the quality of the product and process for the assigned cell culture product line(s).
Day to Day Responsibilities:
+ Provide product team support including, CAPA, customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
+ Provide complaint and customer service point of contact and problem resolution – to include Questionnaires, Certificates, SCARS and Customer Surveys etc.
+ Aid in investigation of Corrective and Preventive actions (CAPA), Situation Analysis (SA) and Health Hazard Evaluation (HHE), and customer complaints with clear documentation of corrective actions. Communicate customer feedback to Quality Systems group.
+ Coordinating with the PLMs to aid the compilation of standard validation guides for the Cell Culture product families.
+ As needed, coordinate discussions on internal defects, incoming inspections, and inventory quality concerns with plant operations.
+ Support Corning Life Sciences (Tewksbury) with Customer Notification Letters from Cell Culture product projects as needed.
+ Apply quality engineering practices and guidance to support project teams and manufacturing operations using existing methodologies.
+ Support Continuous Improvement/PeX activities and key plant projects.
+ Develop/Revise Quality Control Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
+ Perform trending and data analysis from key quality indicators: complaints, incoming inspection, and non-conformances.
+ Implement proven inspection and metrology improvements and associated training.
+ Review and guidance to key documentation of the Cell Culture products.
+ Support the creation of technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
+ Serve as a resource for performing internal audits to ensure quality system compliance.
+ 25% domestic east coast travel is required as part of the job responsibilities.
Hours of work/work schedule/flex-time:
+ Position open to working out of multiple facilities: Kennebunk, ME or Tewksbury, MA.
+ Future ability to flex and work from home on occasion.
+ Standard business hours; Monday – Friday.
+ Bachelor’s degree in an Engineering, Science or Statistical field.
Required Years and Area of Experience:
+ Minimum of 4 years of manufacturing quality engineering experience.
+ Minimum 2 years’ experience in validation application.
+ Working knowledge of use and application of cell culture method of use protocols.
+ Previous exposure to regulatory industry requirements ISO9001, ISO13485, and Quality Systems Regulation CFR 21 part 820, GDP / GMP-Good Doc / Good Manufacturing Practices.
+ Working knowledge of databases, including PeopleSoft, Access, spreadsheet applications, Microsoft Project, Minitab and word processing, to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
+ Knowledge of manufacturing processes and relevant statistical methods for quality assurance, i.e.
+ Good understanding of statistical applications and validation.
Desired Experience / Qualifications / Skills:
+ Cell Culture application knowledge and experience.
+ Capable of obtaining Certified Quality Engineer recognition by ASQ.
+ Experience with Six-Sigma/Lean/Continuous Improvement/PQA; certification(s) preferred.
+ Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product and project teams.
+ Ability to propose solutions regarding product disposition and corrective and preventive action effectiveness.
+ Comfortable in giving directions to accomplish work you’re leading.
+ Must be action oriented, make informed decisions, be self-motivated, capable of influencing without authority.
+ Must be an effective communicator (written and verbal), organized, motivated, focused on details with ability to think analytically and use problem solving skills.
+ Flexibility to assume ownership on projects and coordinate the efforts of others to complete project goals or participate on a team to support other project Leads.
+ Able to react to change.
This position does not support immigration sponsorship.
We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, or veteran status or any other legally protected status.
Nearest Major Market: Portland Maine
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