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