Job Description

Requisition Number: 71025

 

The company built on breakthroughs. ​  
Join us.​  

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.  ​  

 

How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward. ​  

 

​At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.​   

 

​Come break through with us.  

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

Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for Mediatech Inc. dba J R Scientific (JRS). Responsible for new product setup, quality project management, and regulatory compliance of serum products. Ensure compliance to in-house and/or external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Day-to-Day Responsibilities

• Ensure compliance to new and changing regulations affecting JRS products and processes including, but not limited to, QSR’s, global import/export regulations, etc.
• New product setup and management of related projects 
• Maintain supplier quality assessment records and interface with serum suppliers.
• Assist with Supplier audits, as needed
• Collaborates with USDA on regulatory compliance activities including regulatory approvals, import/export compliance, traceability, quarantine, safety testing and affidavits.
• Serve as a resource for customer’s regulatory and technical inquiries 
• Ongoing maintenance of JRS’ ISO 13485 based quality system
• Implement and handle CAPA (Corrective and Preventive Actions) and problem resolution. 
• Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
• Coordinates the review and revision of procedures, specifications, and forms to maintain and improve the QMS.
• Assist with Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc. 
• Perform Internal Audits in support of internal requirements, 21 CFR 820 and ISO 13485 compliance.
• Assists in representing JRS in customer quality audits, supplier quality audits and regulatory inspections
• Performs investigations and analysis activities to support resolution of quality issues.
• Collaborates with organizational teams to support quality system implementation.
• Creation of new product master files satisfying customer and quality system requirements

Additional Responsibilities

• Ensures quality standards by following company & departmental policies & procedures including, but not limited to:
  • Product performance & quality verification.
  • Identifying, recording, and investigating problems related to product, process & quality systems.
  • Evaluating processes for improvements and standardization.
  • Initiating action to prevent non-conformance in products, process, and quality systems.
• Training on quality systems and applicable regulations as identified by supervisor and required by position.
• Tracking/trending aspects of the QMS.
• Other job duties as required 

Experiences/Education - Required

• Minimum of Bachelor’s degree in Science, Engineering, Bioengineering or related field. Prefer Chemistry or Biology degree programs.
• Thorough knowledge and practical application of Quality Systems Regulations 21 CFR 820 and ISO 13485
• Ability to develop, update and train on SOPs.
• Working knowledge of ISO standards and Quality Management Systems (QMS).
• Problem solving techniques to perform investigations and drive root cause analysis.
• Related work experience performing internal/external audits.
• Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products.
• Experience with Continuous Improvement, Lean or Six Sigma. 

Experiences/Education - Desired

• Minimum 3 years’ experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry. 
• SAP, EtQ and/or PeopleSoft experience.
• Experience with statistical analysis.
• Project management experience.
• Animal by-product import/export regulations 
• Animal health and/or virology, immunology, epidemiology knowledge 

 

This position does not support immigration sponsorship.  

 

 

The range for this position is $96,254.00 - $132,349.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position are dependent on hours worked and may include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.

 

 

A job that shapes a life.  

Corning offers you the total package.  

 

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial, and career from day one

• As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit that grows throughout your career. We also offer a 401(k) savings plan with company matching contributions.  
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, and disease management programs. 
• Company-wide bonuses and long-term incentives, align with key business results and ensure you are rewarded when the company performs well – when Corning wins, we all win.     
• Getting paid for our work is important but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a peer-to-peer recognition program to celebrate success by recognizing colleagues who demonstrate above-and-beyond behaviors.  

 

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. To request an accommodation, please contact us at [email protected] .

Job Tags

Full time, Work experience placement,

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