Overview
Manager, Quality Engineering Jobs in at Intuitive Surgical
GMP QA Consultant (Remote)
This is a 6-12 month assignment with potential for extension based on performance.
Our client is a growing biopharmaceutical company developing stem cell-based therapies to treat rare diseases for patients around the globe.
This consultant will be responsible for supporting document reviews, SOP development, and batch record review. This consultant will play a critical role in supporting the client’s clinical manufacturing, and process development teams.
Clinical batch record review
Drafting of SOP’s
CDMO document review
Review process validation, method validation protocols/reports
Establish documentation control
Ensure timely batch releases and completion of QA tasks through collaboration with other stakeholders
Ensuring all aspects of manufacturing adhere to GMP regulations and guidelines.
BS Degree in a science-related field
5-10 years of experience in Biotechnology or Pharmaceuticals
Strong experience with Batch Records, CAPA, Deviations, Change Management
Direct experience developing SOP’s
Strong knowledge of GMP requirements
Experience with Phase I clinical trials
Understanding of Stem-cell based therapies preferred
Job Types: Full-time, Contract, Temporary
Pay: From $45.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Vision insurance
Schedule:
Monday to Friday
Work Location: Remote
Show more
Title: Manager, Quality Engineering
Company: Intuitive Surgical
Location:
