Deviation Management Specialist I Assistant

Spectraforce Technologies
United States, Pennsylvania, West Point
Nov 11, 2024
Title: Deviation Management Specialist - I (Assistant) Location: West Point, PA 19486 United States Duration: 12 Months Qualifications: 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 Demonstrated ability to work both independently and as a part of a cross-functional team Excellent written and verbal communication skills Responsibilities:* 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 Manufacturing Division (MMD) This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations 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 Comments/Special Instructions Technical Writing/investigation experience. Time management/organizational skills. Demonstrated capability of meeting goals/timelines Will need to be able to reach out to others. Organized. Initiative (willing to jump in and learn). Problem solving Typical Day- morning/afternoon meetings review work, Figure out details of investigation, Determining root cause, Problem solving- example-Interviewing technicians to get information Impact to business.