Summary/Purpose of Job
To perform analytical, validation and quality control operations, to evaluate the quality of products through testing and to support Quality Unit activities.
Essential Duties/Responsibilities
Analytical/QC Tasks:
- Execution, writing and/or approval of qualification, validation and stability protocols and/or reports
- Development of In-Process-Control test procedures
- Performing QC testing and/or release of cGMP materials as needed
- Review and approval of analytical data and results
- Writing and approval of QC and analytical documentation
- Maintenance of Quality Control related documentation (QC SOPs and methods, test methods, analytical validation and/or qualification, reference standard qualification, and stability studies)
Other:
- Helping create a positive work environment
- Other reasonable duties may be assigned as necessary
Qualification Requirements
- Minimum of a bachelor’s degree in chemistry
- At least 5 years experience in analytical testing in cGMP environment
- cGMP training including FDA and ICH guidelines
- High level of proficiency in using Agilent chromatographic instruments
- Ability to write/type/review large volumes of information with excellent attention to detail
Physical Demands/Work Environment
- Ability to safely handle hazardous materials
- Ability to move 50 pounds
- Ability to bend to reach floor level
- Ability to wear respirator
