Job Order: 5119
Staff Representative: Tim Jadwin
Position: Senior Quality Engineer
Location: Illinois
Company Summary:
Our client, a large pharmaceutical company, is dedicated to serving patients by providing innovative products that improve their lives with better healthcare. With a foundation built on a robust, early-stage pipeline, our client is a world class pharmaceutical company.
Description:
Objective:
The Senior Quality Engineer supports Quality Assurance by directly interacting with external manufacturers, packagers, and contract laboratories to ensure the quality of marketed products and compliance with FDA regulatory requirements and quality expectations. This position focuses on strategic projects and new product introductions and provides critical recommendations to management through Quality audit leadership.
Accountabilities:
- Perform strategic systems reviews and risk/benefit analyses on vendor manufacturing and packaging processes and related Quality Programs to ensure compliance with current Good Manufacturing Practice (cGMP) regulations and quality expectations.
- Lead Quality Systems audits of existing vendors to assure continued compliance with cGMP’s and quality expectations.
- Lead audits of proposed vendors in support of commercial product business needs. Make recommendations to management concerning the use of suppliers based on audit findings.
- Resolve systemic production issues and support critical product disposition decisions as necessary for product release.
- Represent Commercial QA during critical projects or start-up activities at third party vendors to assure all quality and project expectations are met.
- Ensure internal compliance to cGMP regulations and policies through evaluation of internal supply chain processes, design/implementation of system improvements, and creation/revision/approval of Quality Assurance guidelines, policies, and procedures.
- Bachelor’s Degree in Chemistry, Engineering, Biology, or related
- Minimum 6 years of QA/QC experience in the pharmaceutical industry
- Minimum 8 years experience in pharmaceutical manufacturing, packaging, or laboratory environment
- Demonstrated teamwork, initiative, and problem solving skills
- Strong oral/written communication skills
- Up to 15% travel required
- Day trips to packaging or laboratory facilities requiring drives up to 2 hours
- Domestic and international flights with overnight stays required
