Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Quality Compliance Specialist (Change Controls) role.
Rezi rewrites your resume against Regeneron Pharmaceuticals's job description. Free.
Tailor your resume to this Quality Compliance Specialist (Change Controls) role.
Rezi rewrites your resume against Regeneron Pharmaceuticals's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Quality Compliance Specialist (Change Controls) posting at Regeneron Pharmaceuticals — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Quality Compliance Specialist (Change Controls) posting at Regeneron Pharmaceuticals — free, in seconds.
About the Role
Regeneron is seeking a Quality Compliance Specialist to focus on internal change controls, ensuring quality and compliance with cGMPs, internal, external, and international requirements. This role offers the opportunity to contribute to a science-driven organization making a difference to patients worldwide.
Responsibilities
- Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory, and SOP requirements.
- Facilitate cross-functional meetings, offering guidance and consultation to change control owners.
- Build strong relationships with end users, serving as a go-to resource on standard change control processes.
- Partner 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, translating them into departmental systems, procedures, and documentation.
- Support regulatory and customer audits as a subject matter expert on change control.
- Apply strong working knowledge of biotech/pharmaceutical quality systems, including cGMP, FDA regulations, and familiarity with ICH guidelines and global regulatory standards.
- Analyze and interpret process and systems information, technical procedures, reports, and regulations to support sound decision-making in a cGMP environment.
- Leverage strong digital proficiency in MS Word, Excel, and PowerPoint.
Requirements
- B.S in life sciences or related field; may substitute proven experience for education requirement.
- Experience with Veeva/QMS is a plus.
Skills
- cGMP
- FDA regulations
- ICH guidelines
- Global regulatory standards
- MS Word
- Excel
- PowerPoint
Location
- Rensselaer, New York, United States
Work Type
- Onsite
- Monday-Friday, 8am-4:30pm
Experience Level
- 0-2+ years of experience (Associate Quality Compliance Specialist)
- 2+ years of experience (Quality Compliance Specialist)
- Level will be determined based on experience
Education Level
- B.S in life sciences or related field
Salary/Compensations
- $62,355.00 - $110,000.00
Benefits
- Student loan paydown program & tuition reimbursement
- Family care benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
About the Company
- At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
- Regeneron offers a competitive and comprehensive total rewards package.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.