Quality Control / Documentation Analyst

Katalyst Healthcares & Life Sciences
  • Lexington, MA
  • Instant Apply
30+ days ago

Job Description

Job Description:
  • Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team.
  • This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
  • In this role, the primary responsibility for the individual in this position is to assist in instrument/method projects with some supervision. The projects may require attending meetings based on the specific project, document writing/revising to ensure compliance with regulations and quality control practices.
  • The person in this role may also be asked to revise documents to assist in the daily operations of the team.

Responsibilities:

  • 75% Executing experiments and procedures as detailed by lab manager and staff.
  • 25% Writing /revising documents procedures and validation documentation.

Education and Experience Requirements:

  • Essential: Minimum Bachelor's degree in Chemistry/Biology/Biochemistry.
  • Desired: Experience in a laboratory environment is preferred.
  • Experience with Matlab or other chemometric software.

Numbers & Facts

LocationLexington, MA

Skills

  • Analysis Skillsunmatched
  • Biochemistryunmatched
  • Biologyunmatched
  • Chemistryunmatched
  • Document Managementunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Laboratoryunmatched
  • Laboratory Managementunmatched
  • MATLABunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Operational Supportunmatched
  • Operationsunmatched
  • Quality Assurance Methodologyunmatched
  • Quality Controlunmatched
  • Regulatory Complianceunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Testingunmatched
  • Validation Documentationunmatched

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