Assoc QA Validation Specialist

Regeneron Pharmaceuticals

1d • $62,355 - $92,400

About The Position

Validate and qualify equipment, systems, and processes in accordance with regulatory requirements, while supporting and implementing company manufacturing standards, policies, and procedures. The role generates, executes, and/or reviews qualification and validation protocols, reports, and associated data; analyzes test results against predetermined acceptance criteria; and investigates and troubleshoots issues. It also reviews and approves quality and change-control documentation, coordinates validation activities with internal departments and external vendors, trains or advises less experienced specialists, manages projects, and prepares status reports. The position may oversee contingent workers and may be assigned other duties by management.

Requirements

• Ability to maintain integrity and honesty.
• Ability to work independently or as part of a team.
• Ability to communicate transparently.
• Basic working knowledge of Microsoft Word, Excel, and PowerPoint.
• Ability to gather and organize information.
• Ability to meet commitments on time and follow directions while performing well-defined tasks.
• Effective time-management skills.
• Ability to identify continuous improvement needs and drive process improvements.

Nice To Haves

• BS/BA in Engineering, Chemistry, or Life Sciences.
• 0–2+ years of related experience in the field; relevant experience may substitute for education.

Responsibilities

• Generate, execute, and/or review master and completed qualification and validation protocols, summary reports, and associated data for compliance with regulations, SOPs, specifications, and applicable acceptance criteria.
• Analyze test results and determine whether they meet predetermined criteria.
• Investigate and troubleshoot problems and determine solutions or recommend changes and improvements.
• Review, edit, and approve deviation notifications, deviation investigations, and corrective actions.
• Review, edit, and approve change controls, SOPs, reports, and other documentation.
• Coordinate with other departments and outside contractors or vendors to complete validation tasks.
• Train or advise less experienced Specialists.
• Manage projects and prepare status reports.
• Oversee contingent workers, when required.
• Perform other duties assigned by management.

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match, depending on country and role.
• Health and wellness programs, depending on country and role.
• Fitness centers, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, depending on country and role.
• Paid time off, depending on country and role.
• Family support benefits, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level