Specialist, Quality CMC Operations
Insmed · Corporate Headquarters, NJ
CMCFull-timeCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Insmed seeks a Quality Specialist to support pharmaceutical quality assurance activities for pipeline products at their New Jersey headquarters. The role involves batch record review, product release processes, regulatory compliance documentation, and cross-functional collaboration in a hybrid environment.
What they're looking for
- Bachelor's degree in Chemistry, Life Science, or related discipline
- Minimum 3 years pharmaceutical company quality assurance experience
- Knowledge of cGMP regulations and pharmaceutical manufacturing processes
- Demonstrated batch record review and product release experience
- Proficiency with electronic document management systems and Microsoft Office
- Strong written and verbal communication skills with excellent attention to detail
- Veeva Quality Vault system knowledge highly desirable
What you'll be doing
- Review and approve batch records, certificates of analysis, and related documentation for drug substance and product
- Generate certificates of release and create lots in electronic systems with document uploads
- Ensure compliance with pharmaceutical quality regulations and batch disposition guidelines
- Resolve quality-related issues collaboratively and support timely product release
- Develop and maintain standard operating procedures for batch disposition and quality processes
Compensation$39.00-$50.00 Hourly
Privacy & handoff
This role links to Insmed's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.