What we offer

Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable.

At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork.

Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.

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JOB DESCRIPTION SUMMARY

This position supports the manufacturing operations through the review / approval of batch production records, deviations, change controls and other documentation ensuring compliance with cGMP and ISO9001 requirements.

This work is done primarily independently but may be supported by the mentorship and guidance of the area Quality Assurance Representative.

RESPONSIBILITIES

• First point of contact for production issues and compliance questions
• Provide or approve the initial assessments for all minor quality events and obtain guidance on significant quality events.
• Collaborate with Operations, then review and approve minor deviations and change controls.
• Review validation documents.
• Disposition GMP API and final intermediate batches produced in the production area and support autodisposition of non-final intermediates.
• Approve Master Production Records.
• Review and approve process start up activities.
• Provide oversight for audit related activities such as equipment use logs, quarterly housekeeping, etc.
• Contribute to continuous improvement via membership on project teams (eg., efficiency projects and implementation of new standards)

REQUIREMENTS

• BS in chemistry, engineering, science, or equivalent experience
• Must have at least 3-5 years industrial experience in a GMP environment with good technical understanding of the GM regulation and applications
• Application of GMPs have been demonstrated with experience in many aspects of the quality systems, such as change controls, deviation investigations, and validation writing
• Good communication skills (written and verbal)
• Ability to work in an undefined environment, and closely collaborate with teammates on a routine basis
• Computer skills - Microsoft Office Suite (word, excel, etc). Prior experience with SAP preferred, prior experience with TrackWise preferred
• Must provide 24 / 7 coverage for areas supported, willing to occasionally work nights and weekends.

Last updated : 2024-05-11