Manufacturing Associate I Job at SGS Consulting, Washington DC

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  • SGS Consulting
  • Washington DC

Job Description

Job Responsibilities:

  • Compile and perform lot file review including assessment of manufacturing records, test method data, deviations for GMP compliance to enable lot release, specifically:
  • Review executed batch production records and test data to ensure compliance with approved procedures and GMP expectations
  • Review certificates of analysis c. Evaluate discrepancies noted during batch record reviews d. GMP incident/deviation review
  • Apply the principles of good quality systems and GMP, as assigned on a daily basis
  • Create and revise standard operating procedures (SOP’s) as needed
  • Assist with the reporting and presentation of department metrics includes input into reports to Management, annual product quality reviews and process monitoring
  • Assign part and lot numbers and maintain logs
  • Periodic review of validated systems
  • Review validation deliverables for compliance with Seattle Genetics policies and procedures

Skills:

  • Demonstrated experience in a biotechnology manufacturing or laboratory environment
  • cGMP

Education/Experience:

  • High School

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