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
Requirements:
- 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
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