Deviation Management Specialist/Quality Assurance jobs in United States
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AllSTEM Connections · 1 week ago

Deviation Management Specialist/Quality Assurance

AllSTEM Connections is seeking a Deviation Management Specialist to provide technical support to manufacturing operations. The role involves resolving process deviations, developing corrective actions, and conducting investigations within the manufacturing division.

Professional ServicesRecruitingStaffing Agency
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H1B Sponsor Likelynote
Hiring Manager
Gulshan K
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Responsibilities

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 Manufacturing Division
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

Qualification

CGMP experienceLean Six SigmaInvestigation writingAnalytical problem solvingCross-functional teamworkWritten communicationVerbal communication

Required

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 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

Company

AllSTEM Connections

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AllSTEM Connections is a provider of staffing and recruiting services.

H1B Sponsorship

AllSTEM Connections has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)

Funding

Current Stage
Late Stage
Company data provided by crunchbase