Job Description
Qualifications Bachelors with major in Chemistry or related scientific discipline with a minimum of 6 years of experience in a QC laboratory environment OR equivalent combination of relevant education and experience may be substituted as appropriate Investigations experience including root cause analysis, writing, and CAPA identification Responsibilities Investigation & Root Cause Analysis Work with cross functional team to meet required investigation deadlines in a proficient manner, while driving to root cause, and identifying the appropriate & effective corrective and preventive action. Conduct, document, and approve deviation investigations as needed, while also working with customers as required. Conduct, document, and approve OOS investigations, including coordination with customers as required by quality agreements and regulatory commitments. Apply 6M, 5 Why or fishbone analysis to drive root cause All investigations will follow procedures in accordance with cGMP’s. Work with the team to document and drive critical investigations to closure. Quality Events & Compliance Ensure Quality Events are initiated in a timely manner, initial impact completed and QA approved in a timely manner Work with the QA manager to ensure extensions are in place prior to the due date when Quality Events are not completed by the due date Ensure all investigations are executed in full compliance with cGMPs, Curia SOPs, and global quality standards. Metrics, CAPA & Continuous Improvement Maintain metrics for the laboratories to identify CAPA opportunities including, analyst error rate, equipment failure rate, and test method issues. Identify CAPA’s and update training modules to reduce analyst error rate Collaboration & Reporting Work with the team to develop investigation strategies to meet customer commitments and requirements. Provide investigation updates to cross functional areas and management, as required. Ownership Work independently as the primary QA investigator and QA approver for Quality Events