Associate QA Validation Specialist

About the role

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

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.
• Some travel may be required.

Requirements

In order to be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and 0 – 2 years of relevant experience for an Associate, 2+ years of relevant experience for a Specialist, 5+ years of relevant experience for a Senior Specialist, 8+ years of relevant experience for a Principal Specialist. Proven experience may be substituted for the education requirement.

Skills

• 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
• Basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
• Gathers and organizes information
• Meets commitments on time
• Performs well-defined tasks
• Effective time management skills
• Seeks to identify continuous improvement needs

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs,