QMS & Regulatory Affairs Associate

Corning • Woodland, CA

106d • $96,254 - $132,349

About The Position

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. 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. 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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Medical, dental, vision insurance
• 401(k) plan with company matching contributions
• Pension plan
• Life insurance coverage
• Disability benefits
• Paid parental leave
• Family building support
• Fitness programs
• Company-wide bonuses and long-term incentives
• Peer-to-peer recognition program

What This Job Offers

• Job Type: Full-time
• Industry: Nonmetallic Mineral Product Manufacturing
• Education Level: Bachelor's degree