As a QA Specialist, you will support the QA management personnel in the execution and maintenance of the company's GxP Quality Systems.
Daily Responsibilities:
1. Assist with investigations and corrective and preventive action (CAPA) relating to quality systems.
2. Participate in authoring, reviewing, and approving Standard Operating Procedures (SOPs), Deviations, Change Controls, and other types of controlled documents.
3. Participate in internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP.
4. Organize site training on QMS elements such as GMP Induction and GMP refresher.
Education and Experience:
1. 4+ years of relevant experience in a GMP environment related field and a BS.
2. Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems).
3. Knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.
#J-18808-Ljbffr