QA Project Manager - GMP Quality & Customer Liaison

Evonik; Lafayette (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Evonik Tippecanoe Laboratories is seeking a QA Project Manager to bridge the Quality Assurance group with customers and 1M project managers. The role requires interpreting regulatory guidance for new processes and projects and maintaining GMP quality systems.

The position has a high impact on company revenue, with responsibilities spanning customer audits, deviations, and quality agreements, in a fast-evolving environment.

Qualifications

• BS in chemistry, engineering, science, or equivalent experience.
• 5+ years industrial experience in a GMP environment or equivalent training.
• Broad knowledge with respect the GMP compliance for a wide range of products (i.e. APIs, Food Additives, Excipients, etc.)
• Able to apply compliance standards to daily production situations
• Good communication skills
• Ability to work in an undefined environment
• Provide 24/7 coverage and willing to work nights and weekends as needed

Responsibilities

• The "face of the customer" for any quality related issues to ensure the customer's requirements are being met.
• Interface between 1M project managers and QA department.
• Quality system SME (Subject Matter Expert) for Evonik Tippecanoe Laboratories.
• Supports improvements to our local and global Quality Management Systems (QMS).
• Approve changes and deviations that have the potential to impact product quality.
• Host customer audits.
• Issues responses to customer audits and tracks completion of action plans.
• Negotiate customer quality agreements and ensures quality agreement provisions are being met.

Education

BS in chemistry, engineering, science, or equivalent

Job description

Evonik Tippecanoe Laboratories is seeking a QA Project Manager to bridge the Quality Assurance group with customers and 1M project managers. The role requires interpreting regulatory guidance for new processes and projects and maintaining GMP quality systems.

The position has a high impact on company revenue, with responsibilities spanning customer audits, deviations, and quality agreements, in a fast-evolving environment.