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Quality Assurance Specialist Jobs

Company

Evonik
Address , Lafayette, 47909, In
Employment type FULL_TIME
Salary
Expires 2023-06-09
Posted at 1 year ago
Job Description
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 is supported by the mentorship and guidance of the area Quality Assurance Representative.
What we offer
You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.
Click on the link to learn more about Evonik from our employees:
https://careers.evonik.com/en/about/meet-the-team/
RESPONSIBILITIES:
  • Disposition GMP API and final intermediate batches produced in the production area and support autodisposition of non-final intermediates as determined and under the mentorship of Quality Assurance Representative and QA Manager.
  • Provide oversight for audit related activities such as equipment use logs, quarterly housekeeping, etc.
  • Review validation documents supported by the mentorship of Quality Assurance Representative and QA Manager.
  • Provide or approve the initial assessments for all minor quality events and obtain guidance on significant quality events.
  • Provides back up capability of Quality Assurance Representative as first point of contact for production issues and compliance questions
  • Contribute to continuous improvement via membership on project teams (eg., efficiency projects and implementation of new standards)
  • Approve Master Production Records, supported by the mentorship of Quality Assurance Representatives and QA Manager.
  • Collaborate with Operations, then review and approve minor deviations and change controls, supported by the mentorship of Quality Assurance Representatives and QA Manager.
  • Review and approve process start up activities as determined and under the mentorship of Quality Assurance Representative and QA Manager.
  • Provide back room support during customer and agency audits
REQUIREMENTS:
  • Application of GMPs have been demonstrated with experience in many aspects of the quality systems, such as change controls, deviation investigations, and validation writing.
  • May provide 24/7 coverage for areas supported; willing to work nights and weekends as needed
  • Good communication skills (written and verbal)
  • Prior experience with SAP preferred
  • Prior experience with TrackWise preferred
  • BS in chemistry, engineering, science, or equivalent experience
  • Ability to work in an undefined environment
  • Computer skills - Microsoft Office Suite (Word, Excel, Etc.)
  • Must have at least 3-5 years industrial experience in a GMP environment with good technical understanding of the GMP regulation and applications
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. If you have any questions regarding the application process, please call our Talent Acquisition Team at 0800 2386645 (Germany only) or +49 201 177 4200.
Your Talent Acquisition Manager:
Joseph Arko [C]
Company is
Evonik Corporation