Quality Assurance Compliance Specialist, Change Control

Regeneron Pharmaceuticals • Rensselaer, NY

2d • $67,400 - $110,000

About The Position

Regeneron is seeking a Quality Assurance Compliance Specialist to support its Fill Finish facility in Rensselaer, New York. The role ensures quality and compliance with cGMPs and internal, external, and international requirements related to change control activities. The specialist reviews and approves change control documentation, advises proposal owners and end users, supports continuous improvement of the change control system and process, interprets regulatory requirements, and assists with regulatory and customer audits. The position is scheduled Monday through Friday, 8:00 AM to 5:00 PM.

The role may be filled at the Associate Specialist, Specialist, or Senior Specialist level, depending on qualifications. Regeneron describes its workplace as inclusive and diverse and offers a total rewards package that may include annual bonuses or other incentives, equity awards, retirement benefits, insurance, paid time off, and family support benefits, depending on country and role.

Requirements

• Bachelor’s degree in a scientific or engineering discipline, or a related field.
• Relevant experience in quality, production, engineering, regulatory chemistry, manufacturing and control, and/or laboratory work, with demonstrated accomplishments in effectively implementing cGMP requirements. Minimum experience depends on level: Associate Specialist, 0–2+ years; Specialist, 2–5+ years; Senior Specialist, 5+ years.
• Knowledge of biotechnology or pharmaceutical quality systems, including cGMP and FDA regulations, and familiarity with ICH guidelines and global regulatory requirements.
• Ability to work independently with attention to detail, accuracy, and scientific judgment, and to shift quickly between tasks.
• Ability to comprehend, analyze, and interpret process and systems information, technical procedures, reports, and regulations and make decisions in a GMP environment.
• Ability to establish and maintain effective working relationships and influence people at various levels to gain understanding or acceptance of ideas, policies, procedures, or plans.
• Excellent interpersonal, written, and oral communication skills, including active listening.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

Nice To Haves

• Experience in a change control function.
• Experience with Process Compliance/QUMAS.

Responsibilities

• Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements.
• Facilitate cross-functional meetings and provide guidance and consultation to change proposal owners.
• Develop relationships with end users and advise them on change control best practices.
• Collaborate with Quality Assurance team members and system end users to identify, develop, and implement continuous improvements to the change control system, process, and related procedures.
• Interpret compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.
• Support regulatory and customer audits.

Benefits

• Health and wellness programs
• Fitness centers
• Stock for employees at all levels
• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits and a 401(k) company match may be offered, depending on country and role.
• Medical, dental, vision, life, and disability insurance benefits may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

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