Sr Technical Writer
On Assignment, Inc./Oxford Global Resources

Boulder, Colorado

Posted in IT


Job Info


Summary:

Perform tactical work and review a variety of documents, protocols, and reports.

Project Details:

  • Exhibit varying levels of experience and a solid progression of work and/or training
  • Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies
  • Review and approve manufacturing records, change controls, investigations and analytical data
  • Review and approve test methods and method validations
  • Review manufacturing validation protocol and reports

Job Experience:
  • Experience in small molecule manufacturing and contract manufacturing
  • Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
  • A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.
  • Excellent verbal and written communication skills
  • Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
  • Strong analytical skills
  • Effective project management and organizational skills are essential
  • Knowledge and understanding of quality
  • Manufacturing processes and procedures, planning, supply chain, inventory management

Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefits@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.



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