Position Title: Site Validation and Non-Conformance Specialist

Business Title: Site Validation and Non-Conformance Specialist

Entity: Consumer Products Services Division

Department: CPS - ATL

Location: Cincinnati, Ohio

Reports to: Senior Site Manager

FLSA: Hourly

 

Hours Worked: Monday through Friday, forty hours per week. However, must be flexible to meet the needs of the department and complete other projects as assigned.

 

Compensation Range: $21 - $25 an hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).

 

Position Summary:

The Site Validation and Non-Conformance Specialist  is responsible for identifying, investigating, and resolving quality issues that deviate from established standards within a manufacturing or service environment, ensuring timely corrective actions are taken to maintain product quality and compliance with regulations, by meticulously documenting non-conformance reports, analyzing root causes, and collaborating with cross-functional teams to prevent future occurrences. 

 

Duties and Responsibilities:

Coordinate the activities associated with the site master validation plan and nonconformance process by supporting engineers, gauge owners and management of a research and development laboratory Locate unique gauges, fixtures, and equipment across multiple buildings on campus to create and maintain inventory records, while also conducting reviews for conformance. Maintain rapidly changing data and perform database queries regarding usage of gauges or measurement devices that have been found out of tolerance Communicate effectively amongst a cross-function team of engineers, technicians and QA representatives in multiple departments to provide status information of Corrective Actions and pending resolutions Multi-task effectively and perform other support tasks and other duties as assigned. Work across organizational boundaries, interfacing with multiple disciplines including Management, Engineering, Quality, and Calibration personnel to minimize nonconformance cases and work towards alignment with the site master validation plan Perform other task and duties as assigned.

 

 

Skills & Proficiencies:

Ability to travel to different facilities in Blue Ash and Springboro. Intermediate to Advanced knowledge of Microsoft Office applications. Proven experience with complex documentation management and database driven computer systems is desired. Self-driven with ability to prioritize based on impact to business and deadlines. Detail oriented, organized, and capable of working independently The ability to effectively communicate and ensure alignment between collaborative organizations is required. Preferred: Experience in R&D lab settings is a strong plus. Experience with the database Maximo is a strong plus. Familiarity with calibration documentation is a strong plus. Prior experience in a highly regulated environment.

 

Education and Experience:

2-year degree in STEM background, Regulatory Affairs or Business Administration. 1+ years’ experience in a technical administrative role.

 

An equivalent combination of education and experience may be accepted in lieu of above.