QC CSV Specialist
Michigan, Lansing-East Lansing
Our client, a Global Leader in the Life Sciences sector providing specialty products for populations that address accidental, intentional and naturally occurring health threats has an immediate opening for a Sr QC CSV Specialist for a 6 month + Contract. This position will generate, review and execute validation documentation associated with customer software for pharmaceutical requirements.
Job Requirement / QC Systems Support:
Author / revise protocols and associated specifications.
Core understanding of applicable compliance / guidelines / regulations (ISO, USP, FDA, EU)
Uses cGMP and scientific expertise to support internal and external audit activities.
Familiarity / Expertise with GAMP 5 methodology
Education & Skills:
Bachelor s degree required
2-3 years minimum Technical Writing experience required
2-3 years minimum experience in a CSV (Customer software qualification experience highly desired)
2-3 years experience with Pharmaceutical Documentation generation such as User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS) Configuration Specifications (CS), Installation and Operational Qualification (IOQ) and Performance Qualifications (PQ)
GMP experience 2-3 years.
Knowledge of GAMP 5 a plus
Experience with JMP and SAS a plus
Ability to adapt to a fast-paced environment
Ability to work with cross functional teams
Can work independently to generate documentation