Deviation Management Specialist

Job ***** Deviation Management Specialist ***** 12+ Months ***** West Point, PA, 19486 Pay ***** $35 - $41.78 /hr. Depending upon Experience. Intelliswift Software Inc. conceptualizes, builds, and supports the worlds most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT and Talent solutions. We specialize in delivering world-class Digital Product Engineering, Data Management and Analytics, and Staffing Solutions services to Fortune companies, SMBs, ISVs, and fast-growing startups. Job ***** ***** · Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations · This individual will be responsible for providing scientific support for manufacturing areas within Clients Manufacturing Division (MMD) · Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required · Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required · Off-shift work may be required. ***** Investigation Writing experience- Top skillset needed Nice to have- previous DM experience, root cause analysis experience · B.S./M.S. degree in appropriate engineering/scientific field · Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry · Previous experience in writing investigations for atypical events in a manufacturing environment · Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities

Created: 2025-05-24