Quality Compliance Specialist
Regeneron Pharmaceuticals•Rensselaer, IN
•$67,400 - $110,000•Onsite
About The Position
Regeneron is seeking a Quality Compliance Specialist to join its Quality Assurance team, focusing on internal change controls. The role ensures that change control activities comply with cGMPs and internal, external, and international requirements. The position is based in Rensselaer, New York, and follows a Monday–Friday schedule from 8:00 a.m. to 4:30 p.m. The role level will be determined based on experience.
Requirements
- B.S. in life sciences or a related field; proven experience may substitute for the education requirement.
- At least 2 years of experience for the Quality Compliance Specialist level; the Associate Quality Compliance Specialist level requires 0–2+ years of experience.
- Strong working knowledge of biotech or pharmaceutical quality systems, including cGMP and FDA regulations.
- Familiarity with ICH guidelines and global regulatory standards.
- Strong proficiency with MS Word, Excel, and PowerPoint.
Nice To Haves
- Experience with Veeva/QMS.
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 control owners throughout the process.
- Build relationships with end users and serve as a resource on standard change control processes.
- Work with Quality Assurance colleagues and system end users to identify, develop, and implement continuous improvements to the change control system, processes, and related procedures.
- Interpret compliance and regulatory requirements and translate them into departmental systems, procedures, and documentation.
- Support regulatory and customer audits as a change control subject matter expert.
- Analyze and interpret process and systems information, technical procedures, reports, and regulations to support decision-making in a cGMP environment.
Benefits
- Student loan paydown program
- Tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture, and well-being programs, including physical and mental health programs
- Potential annual bonuses or other incentive plans
- Potential equity awards
- Potential pension or retirement benefits
- Potential 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits, including medical, dental, vision, life, and disability insurance
- Paid time off
- Family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
