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Deviation Management Specialist

Company:
Lancesoft Inc.
Location:
Durham, North Carolina, United States
Posted:
August 09, 2019

Description:

Qualifications:

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

• Minimum of 2-5 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 Environmental Monitoring (EM) 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 Merck’s 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