Quality Assurance Analyst

Evonik•Lafayette, IN

7d•Hybrid

About The Position

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.

Requirements

BS in chemistry, engineering, science, or equivalent experience is preferred.
3-5 years industrial experience in a GMP environment with good technical understanding of the GMP regulations and applications is preferred.
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.

Nice To Haves

SAP and TrackWise experience is a plus.

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.