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Deviation Management Specialist

4 months ago

Lansdale, United States Mindlance Full time

Job Title: Deviation Management Specialist

Job Location: West Point, PA

Zip Code: 19446

Top 3/5 Skills:

1) Investigational Technical Writing Skills

2) Deviation management authorizing experience

3) GMP / Manufacturing

4) Pharmaceutical

Position Details:

Required top skillsets- Investigational Technical Writing Skills and Deviation management authorizing experience

Job overview:

· 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 ***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.

Deviation Management Specialist – Pharmaceutical

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 the 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.