Deviation Management Specialist - I Assistant

Qualifications B.S./M.S. degree in appropriate engineering/scientific field Minimum of 03 years postBachelors 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 crossfunctional team Excellent written and verbal communication skills
Responsibilities Primary responsibilities include daytoday 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 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 Offshift work may be required.
Comments/Special Instructions2 Positions (1 for each manager) Required top skillsets Investigational Technical Writing Skills and Deviation management authorizing experience
System Location: Manufacturing (Z007) Required
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CWR Type: W2 Required