Hiring: CAPA Manager Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-10 13:51:40 Employment Type: Contract Target Skills & Keywords : Microsoft Excel, Microsoft Office, Root Cause Analysis About the job Experience: •Bachelor’s degree required, preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master’s degree with 3 years of pharmaceutical or medical device industry experience •5 years of pharmaceutical or medical device industry experience, including management experience OR master’s degree with 3 years of pharmaceutical or medical device industry experience •Minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master’s degree with 3 years of pharmaceutical or medical device industry experience Required Skills: •Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines. •Oversee day-to-day operation of the CAPA Quality System, including recurring CAPA meetings and timely closure of CAPAs. •Lead and facilitate investigations for deviations. •Utilize structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify root causes and implement effective corrective/preventive actions. •Review and approve CAPA documentation for completeness and accuracy. •Escalate quality issues to Sr. Manager, Quality or Quality Director as necessary. •Train and qualify deviation authors, CAPA and Continuous Improvement (CI) owners and approvers to ensure competency in investigation and documentation processes. •Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement. Qualifications: •Strong knowledge of cGMP, FDA, EMA, and ICH guidelines. •Proven experience managing CAPA systems and leading investigations. •Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools. •Operational familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus. •Duties may require overtime work, including nights and weekends. •Position may require sitting or standing for long periods of time. •In return, you’ll be eligible for [1] Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!