Sterility Assurance Support- Contract- Hayward, Ca

Summary:

As a key member of our Sterility Assurance Engineering (SAE) group under the Manufacturing Science and Technology (MSAT) department, the part-time Consultant is responsible for writing technical documents in support of irradiation sterilization and other SAE projects.  

Duties and Responsibilities:

  • Write technical documentation (SOPs, technical reports, etc.) in support of the Gamma irradiation sterilization program, the NDA resubmission effort, and other microbiological studies.
  • Maintain the archiving program for sterilization validations in coordination with the Quality Documentation department.
  • Provide support to Sterility Assurance Engineering in the execution of irradiation and other sterilization programs as well as other microbiological studies, as necessary.
  • Provide support to quality event documentation pertaining to SAE (Change request, CAPA, quality investigation, etc.).

Qualifications: 

  • Bachelor’s degree in microbiology or other biological sciences with 10 years of industry experience.

Experience: 

  • Minimum of 5 years in pharmaceutical industry with background in sterilization sciences, and process development.
  • Strong technical writing experience with ability to communicate and interact with cross disciplinary teams.

Pay Rate-$55-60/hr.

Possible Contract to Hire

Please send resume to kjohnson@nelsoninteractive.net

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