What are the responsibilities and job description for the Deviation Management Specialist - I position at Careers Integrated Resources Inc?
Job Title: Deviation Management Specialist - I
Job Location: West Point, PA
Job Duration: 12 Months (Possibilities of Extension)
Shift: Work shift: STD
Job Responsibilities:
- Provide day-to-day technical support to manufacturing operations.
- Resolve and reduce process deviations through corrective and preventative actions.
- Lead manufacturing and laboratory investigations.
- Provide scientific support for manufacturing areas within Client’s Manufacturing Division (MMD).
- Develop working relationships with counterparts in aseptic manufacturing, testing, planning, and release.
- Utilize sound scientific and engineering principles to investigate process deviations.
- Perform troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events.
- Develop and implement corrective and preventative actions.
- Analyze complex problems through critical analytical thinking and laboratory/pilot-scale experiments.
- Work off-shift as required.
Qualifications:
- B.S./M.S. degree in an appropriate engineering or scientific field.
- Minimum of 4–8 years of post-Bachelor’s degree experience in a cGMP environment (e.g., Production, Development, Process Engineering, Technical Services, or related field) within the pharmaceutical/biotech industry.
- Previous experience writing investigations for atypical events in a manufacturing environment.
- Familiarity with Lean Six Sigma methodologies and proven analytical/problem-solving capabilities.
- Demonstrated ability to work independently and as part of a cross-functional team.
- Excellent written and verbal communication skills.