Specialist, Quality CMC Operations Job at Insmed, New Jersey

  • Insmed
  • New Jersey

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Compensation: $39.00-$50.00 Hourly

Job Tags

Hourly pay, Work at office

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