QA Auditor

Requisition Number: 52548

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:

In this role, you will review and audit documents and processes for compliance to standard operating procedures, regulations/standards, proper documentation methods and good manufacturing practices. We look for you to assure that internal systems as well as suppliers are in compliance with SOPs, FDA and ISO requirements as applicable. Collaborates with engineering and manufacturing functions to ensure quality standards implemented and followed. You will need to exercise judgment within defined procedures and practices to determine appropriate actions.

Day to Day Responsibilities:

• Performs final audit of Device History Records (DHR) to assure that all activities required in the DHR are completed.
• Plans and participates in customer audit process to assure all customer auditor needs are addressed.
• Assures overall compliance of the supplier management program, including performing supplier audits according to schedule and associated follow up.
• Assures overall compliance of the internal audit program including performing internal audits according to schedule and associated follow up.
• Provides any and all necessary support for regulatory audits.
• Audits documents submitted for QA review for adherence to SOPs and correct documentation practices.
• Spot audits processes and areas within the facility by performing walk-throughs and providing feedback area management on any compliance concerns.
• Reviews and provides feedback on nonconformance reports and CAPA documents to assure root cause analysis is reached and corrections are appropriate to prevent further nonconformances.
• Reviews and makes recommendations for TDRs prior to final QA approval.
• Contributes to trend analysis of NCRs, TDRs, CAPAs, audit findings, and environmental monitoring data. Provides analysis and recommendations for process improvements-based trend reviews.
• Updates relevant QA SOPs to assure they are accurate and up to date with current processes and regulations.
• Reviews and approves SOPs for completeness and accuracy with internal and regulatory requirements.
• Participates in Performance Excellence activities.

Travel Requirements:

• Negligible

Hours of work/work schedule/flex-time:

• Standard business hours; Monday – Friday.

Required Education:

• Bachelor’s degree in the life sciences field or related science fields

Required Skills:

• 1-3 years of work-related experience
• Can apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
• Solid computer knowledge in Microsoft Word and Excel.

Desired Experience / Qualifications / Skills:

• Track record of delivering results.
• Understanding of QC testing methodologies for ease in DHR review.
• Understanding of Manufacturing processes for ease in DHR review.

Soft Skills:

• Can balance team and individual responsibilities.
• Must be detail oriented.
• Able to work well both independently and in a group setting.
• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
• Ability to influence individuals without authority.
• Must be action oriented, make informed decisions, and be self-motivated
• Must be an effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.

This position does not support immigration sponsorship.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, disability status or any other legally protected status.

Nearest Major Market: Washington DC