GMP Quality Operations Specialist - Gardner Resources Consulting
boston, MA
About the Job
Our Pharma client is currently searching for a Quality Operations Specialist with expertise in both development and commercialization of products.
The primary responsibility of this position will be to ensure quality oversight of assigned projects/CMO’s for the clinical/commercial product manufactured and to work cross-functionally providing updates and meeting complex timelines for mission critical deliverables.
Qualified applicants will have the following skill sets:
The primary responsibility of this position will be to ensure quality oversight of assigned projects/CMO’s for the clinical/commercial product manufactured and to work cross-functionally providing updates and meeting complex timelines for mission critical deliverables.
Qualified applicants will have the following skill sets:
- B.S. degree in Life sciences, chemistry or equivalent.
- 5+ years of GMP Quality experience with focus on cGMP compliance and product quality for US and EU. Drug Substance.
- Experience with using risk-based principles and decision making to ensure compliance at all stages of development.
- 5+ years of experience with relevant US, EU and ICH requirements.
Source : Gardner Resources Consulting