QA Analyst

Evonik•Lafayette, IN

11d•Onsite

About The Position

At Evonik, you’re part of a global chemical company working in many sectors that go beyond chemistry. From lipids for tomorrow’s medicines, biosurfactants for green detergents, additives for plastics recycling or membranes to help drive forward the energy transition, you’ll play an essential part in helping the world’s most essential industries succeed. Our success hinges on a diversity of ideas powered by people, not egos. Whether you’re a scientist or engineer, new to the team or established, in business, production, or anything in between – we cheer each other on. Because we believe we can do anything. Explore everything. And Be Part of Something Special! 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.

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 writing
Able to apply compliance standards to daily production situations
Good communication skills (written and verbal)
Ability to work in an undefined environment
Strong computer skills
Strong decision making and problem solving skills
Must provide 24/7 coverage for areas supported, willing to work nights and weekends as needed.

Responsibilities

First point of contact for warehouse and raw material issues and compliance questions
Provide quality oversight of the warehouse area and for raw materials through guiding deviation assessments, attending morning meetings as necessary, and elevating issues as appropriate.
Collaborate with warehouse, QC, and production planning personnel, then review and approve minor deviations and change controls associated with warehouse and raw materials
Disposition any raw materials that do no auto-disposition or that require further investigation prior to approval.
Provide quality oversight of raw material failures and associated investigations.
Provide quality support and approval for sampling protocols, qualifications, temperature mapping documents, etc.
Provide oversight for audit related activities such as equipment use logs, quarterly housekeeping, etc.
Contribute to continuous improvement via membership on project teams (e.g., efficiency projects and implementation of new standards). Provide leadership for complex compliance issues and projects.
Support customer and regulatory audits as needed.