Associate QA Validation Specialist

Regeneron Pharmaceuticals•Rensselaer, IN

3d•$62,355 - $92,400•Onsite

About The Position

The Associate QA Validation Specialist validates and qualifies equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This position is for the cleaning Validation team.

Requirements

BS/BA in Engineering, Chemistry, or Life Sciences
0 – 2 years of relevant experience for an Associate
Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Ability to maintain integrity and honesty at all times
Ability to work independently or as part of a team
Ability to communicate with transparency
Continuously drive to improve processes for improved performance
Demonstrate supportive behavior at all times
Gathers and organizes information
Meets commitments on time
Performs well-defined tasks
Effective time management skills
Seeks to identify continuous improvement needs
May substitute proven experience for education requirement

Responsibilities

Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Reviews, edits and approves deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
Manages projects and prepares status reports.
May present at both internal and external (regulatory) audits
Other duties assigned by management.