Quality Specialist

We're hiring a Quality Specialist to join our Kodak team in Rochester, NY. 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.

Specific Duties and Responsibilities:

• 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.

• Assist in maintaining the Approved Suppliers List and support qualification or requalification activities for suppliers.

• Draft, revise, and maintain SOPs, controlled forms, and related quality documents under supervision to ensure best practices and alignment with current operations.

• Support monitoring systems and activities that may impact GMP operations.

• Support coordination with QC laboratory personnel as needed, including documentation review and alignment of GMP records.

• Participate in internal audits of GMP operations and supporting processes, including sample handling, training, testing, reporting, and related LIMS activities.

• Support efforts to ensure test procedures, standards, and specifications remain current with applicable domestic and international regulations.

• Provide quality and technical support to cross functional teams as needed.

• Perform additional duties and responsibilities as assigned by Quality Management.

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.