Reagent Manufacturing Quality Associate at Roche Pharmaceuticals USA

The Reagent Manufacturing Quality Associate will be responsible for qualifying incoming raw materials to support reagent manufacturing. In addition, this person is responsible for preparing reagents for raw material qualification, in-process testing and data analysis. The ideal candidate would have direct experience in a quality control environment and experience with writing SOPs.Responsibilities:

Perform testing for raw materials

Conduct data analysis from raw material test results

Prepare reagents for raw material testing

Document test results, complete batch records, document problems and generate reports

Maintain records and clean room environment to comply with good manufacturing practices and standard operating procedures

Assist in inventory management and ordering materials

Assist in the development of raw material testing processes and documentation

Assist in maintaining laboratory equipment

Assist in the development of physical quality specifications and tests

May assist in transferring processes from development to manufacturing

May assist in testing raw materials for reliability and stability

May assist in reagent manufacturing activities

Support continuous improvement


  • BS/MS in Biochemistry/Molecular Biology or equivalent discipline
  • Minimum of 3-5 years related hands-on experience in a reagent quality testing or reagent manufacturing laboratory
  • Strong technical skills, including a working understanding of molecular biology and biochemistry
  • Demonstrated analytical, troubleshooting, and problem solving skills.
  • Proven math skills
  • Experience with Excel
  • Demonstrated attention to detail and strong organizational skills
  • Strong written and verbal communication skills
  • Proven ability to meet deadlines and work under aggressive timelines
  • Demonstrated ability to work effectively in a team environment
  • Accurate and precise manual pipetting and measuring techniques
  • Experience working with Tecan instruments is preferred, but not required
  • Ability to lift 25 lbs. is preferred, but not required
  • Please submit a resume detailing your experience and education as well as a cover letter for consideration.

QA Specialist III

United States, Oregon, Hillsboro

Function Quality & Compliance

Subfunction Quality Assurance

Schedule Full-time

 Job level Individual Contributor

 Job type Regular Employee

Division Roche Pharmaceuticals

 Job-ID 2566002153