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Assistant Deviation Management Specialist : West Point, PA

LanceSoft Inc.
West Point, Pennsylvania, 19486, United States
October 14, 2019



• Primary responsibilities include 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 Deviation Management support for bulk vaccine manufacturing area.

• This Individual 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 is required

• Off-shift work may be required based on specific assignment.

Required Qualifications and Experience:

• B.S./M.S. degree in appropriate engineering/scientific field

• Minimum of 4-8 years post-bachelor’s 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