Requisition Number: 42565
Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty 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:
Reporting directly to the Quality Manager, this position will support an ISO 9001-compliant Quality management system, driving compliance to QMS processes and continual improvement actions. Responsible for investigating customer issues and complaints providing QA support to the Complaint Management System. Assess and report Quality System performance to appropriate management for review/action as needed. Coordinate training and coach personnel in Quality System requirements and conduct ISO/Good Manufacturing Practice training. Obtain/maintain 9001 auditor certification for internal auditing activities.
Day to Day Responsibilities:
- Manages Change Control process compliance and ensures timeliness in the routing of Quality Management System Documents.
- Responsible for investigating customer complaints and all applicable information to determine accuracy of a complaint, document investigation findings, and drive steps to complaint resolution in a timely manner.
- Collaborates with Customer Service and other company personnel such as Planners, Inventory Control, Warehouse Management System Technician, Receiving or Shipping to obtain facts regarding customer complaints.
- Drive customer complaint meetings as needed to review complaint information and recommend improvements within responsible areas.
- Collects and organizes complaint data related to possible trend and distributes for plant visibility.
- Responds in a timely manner to customer requests through Helpdesk tickets.
- Drives customer issues to resolution to include supporting cross-functional efforts to implement corrective/preventive actions.
- Contributes ideas and suggestions to improve standard, products, processes, packaging, shipping methods, services and procedures to prevent future complaints of similar nature,
- EtQ Administrator for the site: Change Management, Document Control, Training, Complaints, CAPAs/NCMRs.
- Responsible for updating and maintaining employee training files, job specific curriculums, and the Master Training Tracker.
- Assists in the continuous evaluation of the quality system for compliance to ISO 9001:2015 and internal processes/policies.
- Responsible for proper control of documentation and quality records.
- Prepares QMS performance reports for Management Review Meetings.
- Maintains and ensures the confidentiality of information/ materials.
- Support Division/customer/3rd party audits of the site.
- < 5% (training and off-site meetings).
Hours of work/work schedule/flex-time:
- Monday – Friday, standard business hours.
- Flexibility to work over-time under special circumstances
Required Education and Years and Areas of Experience:
- Associate’s degree and minimum 2+ years’ quality systems experience working in a regulated industry (ISO, cGMP, GLP, CFR, FDA, etc.).
- Bachelor’s degree and minimum 0-1+ years’ quality systems experience working in a regulated industry (ISO, cGMP, GLP, CFR, FDA, etc.).
Skills / Experience:
- Thorough understanding of ISO 9001:2015 Quality Management Systems
- Proficiency with Microsoft Office products (Word, PowerPoint, Excel, Visio)
- Able to manage data for analysis and reporting. Understanding of root cause analysis tools (5 Why’s, etc.).
Desired Experience / Qualifications / Skills:
- Experience performing internal audits is strongly preferred.
- Project management experience or skills.
- Must be action oriented, capable of making informed decisions, be self-motivated, capable of influencing without authority.
- Ability to work independently and manage multiple priorities.
- Must be an effective communicator (written and verbal), highly organized, detail oriented with excellent analytical thinking and problem-solving skills.
- Self-starter; ability to drive things to closure.
- Data-based decision-making skills with the ability to use this data in actively finding solutions.
- Excellent organizational skills.
- Initiative and desire to learn.
- Ability to work among a diverse group of individuals.
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.