Quality Assurance Analyst

Evonik•Lafayette, IN

About The Position

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 to ensure that daily manufacturing operations remain compliant with cGMP and ISO 9001 requirements. The person in this role is expected to ensure compliance in the areas that they support through understanding of the compliance requirements of the products produced. The position will provide mentorship to the Assistant QA representative position. 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 Corporation

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 GMP regulations 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 documentation
Able to apply compliance standards to daily production situations
Good communication skills (written and verbal)
Computer skills; experience with Microsoft Office programs required, SAP and TrackWise experience is a plus
Strong decision making and problem solving skills
Must provide 24/7 coverage for areas supported, willing to work nights and weekends as needed
Proven ability to work in a team environment

Responsibilities

First point of contact for production issues and compliance questions
Provide or approve the initial assessments for all quality events
Collaborate with Operations, then review and approve minor deviations and change controls
Review validation documents
Disposition all GMP API and final intermediate batches produced in the production area and support auto-disposition of non-final intermediates (includes resolution of issues)
Ensure adherence to site cleaning program
Approve Master Production Records
Review and approve all 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).
Provide backup room support for customer audits and inspections by regulatory agencies