Deviation Management Specialist
1 month ago
Job Description:
- Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
- Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
- Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.
- Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.
- Assures consistent application of standardized work, engineering, and process tools.
- Provides technical support to manufacturing shop floor for problems and issues.
- Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
- Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
- Bachelor’s degree required, minimum 1 year of experience in GMP environment. Experience with quality assurance, technical writing, or deviation investigations is preferred.
- Pay: $35-41 hourly, depending on experience level
- Onsite, M-F, 8am-5pm, Hybrid schedule after training
- 12-month contract, potential for extension/conversion
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