Change Control Specialist role at Regeneron USA
Regeneron is seeking a Change Control Specialist to enhance manufacturing operations through strategic change control initiatives and CAPA implementation. This role is ideal for professionals pursuing life sciences jobs who excel in quality-driven environments and thrive in fast-paced settings.
Job Details:
- Position: Change Control Specialist
- Department: Manufacturing
- Location: [Specify location if needed]
- Employment Type: Full-Time
- Work Schedule: Monday–Friday, standard business hours
- Salary Range: $59,700 – $126,800 annually
- Reports to: [Specify if known]
- Experience Levels: Associate Specialist (0–2 years), Specialist (2+ years), Sr Specialist (5+ years)
About Regeneron:
Regeneron is a leading biotechnology company committed to advancing science and improving patient lives. The company fosters an inclusive, diverse culture offering employees comprehensive benefits, growth opportunities, and a collaborative environment for life sciences jobs. Apply for more life sciences jobs in the USA.
Educational Requirements for Change Control Specialist role:
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- Relevant experience may substitute for education.
- Level of role depends on experience:
- Associate Specialist: 0–2 years
- Specialist: 2+ years
- Sr Specialist: 5+ years
Key Responsibilities for Change Control Specialist role:
- Develop and implement change control strategies to support manufacturing operations.
- Craft business plans for CAPAs and process improvements.
- Assess proposed changes for compliance with company and regulatory standards.
- Prepare detailed change control documentation including scope, risk, and regulatory impact.
- Review, edit, and maintain controlled documents according to cGMP standards.
- Lead cross-functional meetings to ensure successful change control implementation.
- Mentor teams to achieve GMP-compliant outcomes.
- Monitor multiple projects and resolve obstacles proactively.
- Present critical change controls to senior leadership.
- Document training and assist in onboarding new employees.
- May manage direct reports.
Skills Required for Change Control Specialist role:
- Strong attention to detail and organizational skills.
- Technical writing and interpersonal communication expertise.
- Ability to manage multiple assignments and adapt to changing priorities.
- Knowledge of controlled quality systems (preferred).
- Experience in life sciences jobs or manufacturing quality operations.
Benefits of the role:
- Competitive salary and annual bonuses.
- Health and wellness programs and fitness center access.
- Paid time off and equity awards.
- Inclusive and diverse work culture.
- Opportunities for growth and mentorship in life sciences jobs.
