Quality Specialist

Responsibilities

We are looking for a Quality Specialist to join our Kodak team in Rochester, NY to support our operations. This role supports the implementation and maintenance of quality systems within a GMP regulated manufacturing environment. The near term focus is on executing quality system activities, supporting investigations, documentation, and inspection readiness under the direction of Quality Management. Longer term, this role will provide ongoing quality support to manufacturing as operations ramp and mature. This is a hands on role focused on quality system execution rather than full system ownership.

• Support Quality Management during regulatory agency and customer audits and inspections.
• Promote an ethic of quality in all aspects of the company’s related business activities by supporting GMP and quality requirements in day-to-day operations through consistent application of procedures and documentation standards.
• Support activities related to the GMP Quality Management System (QMS), including execution of quality processes and maintenance of quality records.
• Support execution and documentation of validation and qualification activities for facilities, equipment, GMP systems, and testing procedures under approved protocols.
• Review test results and quality records for completeness and compliance prior to final approval by Quality Management.
• Support maintenance of GMP facilities and equipment records, including calibration, maintenance tracking, and investigation of OOT or excursion events as assigned.
• Assist in ensuring GMP personnel training is completed, documented, and current.
• Support complaint handling activities, including documentation, investigation support, and follow up actions.
• Participate in investigations related to deviations, CAPAs, incidents, OOS/OOT events, and support root cause analysis and corrective actions.
• Support GMP Service and Technical Agreements administration as required.
• Affirmative action statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Qualifications (Education, Experience and Skills)

• Bachelor’s degree is required in a scientific, engineering, or related technical discipline.
• 3–5 years of related experience in an FDA regulated environment, such as medical devices or pharmaceuticals.
• Working knowledge of GMP requirements, quality investigations, root cause analysis, CAPA, auditing principles, document control, and SOP development.
• Experience supporting validation, laboratory operations, inspections, and quality system maintenance preferred.
• Strong attention to detail, documentation skills, and ability to work effectively in a regulated manufacturing environment.

Certifications Preferred

• cGMP, ISO Auditor, ASQ, or similar certifications preferred but not required.

Benefits

Not specified.

Pay

Estimated Salary: $31.00 - $33.50

Schedule

Not specified.

Company

Kodak

Location

Rochester, NY, US, 14652

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

EOE Policy Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Experience Level

0-5 Years

Requisition ID

2016