QA Project Manager

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

What we offer At Evonik, you’re part of a global chemical company working in many sectors that go beyond chemistry. From lipids for tomorrow’s medicines, biosurfactants for green detergents, additives for plastics recycling or membranes to help drive forward the energy transition, you’ll play an essential part in helping the world’s most essential industries succeed. Our success hinges on a diversity of ideas powered by people, not egos. Whether you’re a scientist or engineer, new to the team or established, in business, production, or anything in between – we cheer each other on. Because we believe we can do anything. Explore everything. And Be Part of Something Special! Find out more about the many benefits we offer: https://www.evonik.com/en/careers/why.html Meet the team and get to know the people behind Evonik: https://www.evonik.com/en/news/meet-the-team.html

The QA Project Manager will provide an interface between the Quality Assurance department, Customers and 1M Project Managers and be able to work in an undefined environment with the ability to interpret and apply regulatory guidance to new processes and projects. The position has a high impact on the company's annual revenue. This position requires a broad knowledge of GMP quality systems as well as the ability to stay abreast with industry trends.

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.

REQUIREMENTS

• 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

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

This is your opportunity to join a thriving global organization that combines cutting-edge science, technology and engineering with world‑class business services to create solutions that answer real‑world problems. If you join us, we’ll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you’ll enjoy opportunities to improve and to be respected for your contribution.