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.
Click on the link below to learn what our employees have to say about Evonik:
https://careers.evonik.com/en/about/meet-the-team/
This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation. The position utilizes risk management, quality planning and statistical analysis to complete assigned tasks..
RESPONSIBILITIES
Represent quality department on development project teams.
Review and approve product and process-related documentation.
Support the generation and justification of product and materials specifications.
Provide support for the development of validation strategies and validation plans.
Review/approve protocols and reports.
Support Deviation / CAPA investigations.
Support interdisciplinary teams for root cause analysis of quality deficits using known of problem-solving tools.
Support product quality and System improvements activities.
Support collection and analyze data to identify opportunities for quality improvement.
Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints.
Support to facilitate risk assessment activities such as design and process FMEA.
Ensure product risks are identified, and risk mitigation controls are put in place to eliminate product risk to an acceptable level.
Provide real time production floor QA oversight.
Evaluate manufacturing data for trends and other special causes.
Review and disposition manufacturing / packaging batch documentation.
Perform room / line clearances as needed.
Review and disposition raw materials / components for manufacturing.
- Support resolution of quality issues in manufacturing.
REQUIREMENTS
Bachelor of Science degree in Chemistry, Biology, or Engineering.
Minimum eight years’ experience in pharmaceutical or medical device manufacturing, preferred.
Minimum five years’ experience in a pharmaceutical or medical device Quality Assurance role preferred.
Proficient computer skills, Microsoft Word, Excel, Access.
High attention to detail, organization, and accuracy
Strong written and verbal communication skills.
Good interpersonal skills.
Knowledge of FDA’s cGMP and/or QSR quality system requirements.
Comprehensive technical skills/knowledge · Applied statistics experience, preferred. · Validation experience, including process validation · Advanced analytical and problem-solving skills
Experience in Regulatory Agency inspections.
Experience in aseptic techniques and manufacturing.
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.
Your Application
To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:
Kelvin Seals [C]Company is
Evonik CorporationSkills Required
- Bachelor of Science degree in Chemistry, Biology, or Engineering
- Minimum eight years' experience in pharmaceutical or medical device manufacturing
- Minimum five years' experience in a pharmaceutical or medical device Quality Assurance role
- Proficient computer skills, Microsoft Word, Excel, Access
- Knowledge of FDA's cGMP and/or QSR quality system requirements
- Experience in aseptic techniques and manufacturing
What We Do
Evonik is one of the world’s leading specialty chemicals companies. While we don’t produce electric cars, aircraft, medications or 3D printers, Evonik is part and parcel of these and many other end products. That’s because we contribute the small things that make a big difference. We make electric car batteries perform better, aircraft greener, medications more effective and 3D printers more efficient. In short: We think beyond the bounds of chemistry to make the world a better place. Today and tomorrow. We are an international group with a workforce of over 32,000 people spread across more than one hundred locations. Our daily work is shaped by global concerns, such as sustainability, diversity and digitalization. In all our business decisions, we take the present and future generations into consideration. After all, being ready for tomorrow is our business. Interested in joining our global team? Our wide range of opportunities extends from creative and innovative research through international management all the way to production. Whether you’re studying, starting out in your career or a seasoned professional, come help us make the world a better place. For more information about careers at Evonik, go to: www.careers.evonik.com. #HumanChemistry Find our netiquette on: www.evonik.com/netiquette
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