Sterility Assurance Support- Contract- Hayward, Ca
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.).
- Bachelor’s degree in microbiology or other biological sciences with 10 years of industry 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.
Possible Contract to Hire
Please send resume to firstname.lastname@example.org