- 3 - 5 years of Pharma experience (in an FDA Regulated Environment

- QC or R&D;

- Lab and/or Regulatory Compliance experience preferred

- cGMP experience preferred

- Metrological experience a plus

- Knowledge of FDA Regulations, experience with 21 CFR 210, 211, 58,11

- Understands the Pharma requirements for GDP (Good Documentation Practices) and the accepted document formats

- Documentation experience

- writing SOP

- writing Validation or Research Reports

- writing IQ, OQ, PQ

- writing method validation plans

- Experience in performing IQ, OQ, PQ

- Experience in performing Method Validation

- Salary ?Open

- Willing to travel internationally 25%

Key Responsibilities

- Assist in operation of the documentation management system for EQ documents.

Position is located in the Midwest, I have another in Europe if that would interest you.
Relocation is open to you.

Call Shannon T Chuna
[email protected]