Plant Quality Lead

Requisition Number: 60976

Corning is vital to progress – in the industries we help shape and in the world we share.

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

欧r sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers.

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:The Plant Quality Lead is accountable for product and process compliance to regulatory, customer and Corning Life Sciences standards. As a member of the Plant Leadership Team, the QL shares accountability for overall plant performance for safety, quality, service, and continuous improvement. The QL promotes the creation of a culture of quality throughout the plant and ensures compliance with CLS quality and regulatory systems.

Day to Day Responsibilities:

• Responsible for developing and maintaining plant strategic quality plans and policies
• Accountable for the effective execution of processes carried out by prioritizing and managing people, resources, and budget to accomplish expected requirements and performance
• Engages and provides leadership directions/objectives, coaching, and personal development of associates to perform to their best ability and meet both personal and plant objectives
• Acts as the plant “management representative” for notified bodies and liaison with regulatory authorities and customers, by hosting-related audits and ensuring effective resolution
• Maintains the Quality Systems to ensure compliance to international standards (ISO) and other industry standards such as USP, etc. as applicable
• Ensures that timely, accurate, qualified, and cost-effective testing is performed on Raw Materials, Critical Facility Utilities, In-process Materials, Finished Goods, and Procured Finished Goods
• 确保适当的Assura质量nce and Quality Control resources are available to assist in the resolution of technical issues

Required Education:Bachelor’s Degree in Life Sciences or Engineering (Biology, Biochemistry or similar desirable). MS Degree helpful.  

Required Years and Area of Experience:Minimum of 5+ years of related experience in quality Minimum of 2+ years of manufacturing experience

Required Skills:

• Must be familiar with 21 CFR parts, 820, 210/211, ISO9001, 13485 (Lead Auditor certifications desirable)
• Must have participated in related audits/inspections
• Strong knowledge base in all aspects of Quality including validation, calibration, quality control
• Knowledge of key statistical methods and proficiency in Continual Improvement Methods (Lean / Six Sigma) required

Preferred Experience / Qualifications / Skills:

• 3+ years of experience in Pharmaceutical / Medical Device industry
• Medical device manufacturing and sterilization background, including sterile pharmaceutical processes
• ASQ Certifications (CQA / CQE / CMQOE)
• Production or engineering management
• Certified Six Sigma Black Belt
• Working knowledge and understanding of manufacturing-related accounting and other financial systems including budget processes is beneficial

Corning Puts YOU First!

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.

• 欧r monetary peer-to-peer recognition program is tied to our Values and celebrates you and your colleagues’ contributions.
• Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.
• Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career.
• Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.
• Professional development programs help you grow and achieve your career goals.

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, 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.