Validation Coordinator

Description

SUMMARY
Assists the Regulatory Manager in the day to day maintenance in driving the completion of all required process validation protocols, and maintains quality files by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
* Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ).
* Coordinate with other functional departments to develop and implement validation test plans.
* Ensure validation efforts are conducted in an appropriate and timely manner.
* Derive and document validation plans and protocols (test) to provide objective evidence that equipment, processes, test methods and product meet requirements and are complaint with applicable regulations.
* Interact with individuals from different disciplines (Production, Maintenance, Engineering, and Quality) to plan, execute and complete validation activities.
* Utilize statistical methods to ensure processes are capable / repeatable and sample plans are statistically valid (i.e. scientific sample selection, statistical process capability data analysis statistical process capability software such as Minitab).
* Assist in prepare procedures related to process, equipment, test methods and product.
* Oversee validation testing for new products and process improvements.
* Coordinate and approve vendor protocols (IQ/OQ/PQ) Qualifications.
* Perform and lead risk assessment exercises in support of validation activities.
* Maintain the validation master plan, procedures and strategies.
* Additional duties as requested by management.

SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.

QUALIFICATIONS
To perform this job successfully, an individual must be professional, proactive and positive, with internal and external customers, suppliers, and coworkers.

Education and/or Experience
Associate Degree in related technical field; 5+ years related experience in quality engineering, process or validation engineering including product/process validation in a medical device or other FDA regulated industry; or equivalent combination of education and experience; Strong skills in teaching and performing root cause analysis and corrective actions.

Qualifications

Associates degree.