JOB DESCRIPTION

Specific Tasks:
  • Perform assay development, validation and sample analysis according to SOPs and regulatory requirements with minimal supervision
  • Interpret experimental results
  • Write and maintain study reports, research documentation and laboratory records
  • Review scientific data and ensure the quality meets company SOPs and applicable regulatory requirements
  • Communicate results to supervisor and sponsors
  • Apply knowledge of GLP (FDA, EPA and OECD) and GCP regulations as well as 21
  • CFR Part 11 (electronic records and electronic signatures) as applicable to the work of the department
  • Cooperate with QA, management, colleagues and clients
  • Calibrate/operate/maintain scientific equipment
  • Act as a technical resource for basic troubleshooting of assays and instruments
  • Interact with sponsors and vendors
  • Maintain a clean and safe laboratory environment.
  • Assists with any additional job responsibilities or tasks based on business or departmental needs, as assigned by management.

Qualifications:

  • B.S. degree/equivalent with 5+ years’ working experience, or M.Sc. degree/equivalent with 2+ years’ experience or Ph.D. degree in relevant field, or an equivalent combination of education, training, and experience as deemed appropriate by management
  • Able to conduct lab work independently using established routines and procedures
  • Good understanding of GLP (FDA, EPA and OECD) and GCP regulations (as applicable), as well as 21 CFR Part 11 (electronic records and electronic signatures)
  • Ability to work effectively in a team
  • Experience with instruments, assays and techniques commonly used in the work performed by the department
  • Ability to use computers and software including Windows Operating System and Microsoft Office.

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