In-Process Quality Engineer II

Title: In-Process Quality Engineer II

Job Summary

A leading pharmaceutical company is seeking to expand their Quality Engineering team! The Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and support to manufacturing operations at the St. Louis Plant. The scope of the position includes responsibility in OOS investigations, CAPAs, Exceptions, Change Controls, and Customer Complaints. Serves a technical resource in the Quality function in partnering with Manufacturing, Supply Chain, and other Quality groups.

As a Quality Engineer II, you will:

• Review and approve Exception and OOS investigations, CAPA's, Change Controls, and Customer Complains in TrackWise system
• Organize and document Material Review Boards for product disposition
• Provide direct support for regulatory inspections and customer audits
• Review release packets prior to final release of Finished Goods
• Participate in Root Cause Analysis and Process Improvement teams

As a Quality Engineer II, you need to have:

• BS in Chemistry, Chemical Engineering, related science or similar education
• At least 3 years of experience in QA in a pharmaceutical manufacturing environment
• Experience with quality metrics, manufacturing investigations and product release

As a Quality Engineer II, you should have:

• Knowledge of cGMPs and APIs including ICH Q7, CFR 210 and 211
• Manufacturing or QC experience
• Knowledge of Quality Systems
• Excellent verbal and written communication skills
• Must be authorized to work in the US without sponsorship
• Ability to build and lead effective teams

Salary:

• $80,000 - $85,000