The Quality Control Analyst II supports the manufacturing, validation and process development and stability functions of Aldevron by analyzing GMP projects by through testing, sampling, and completing the applicable documentation.
Essential Duties and Responsibilities:
- Act as primary analyst for GMP projects and completion of appropriate documentation
- Perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment
- Gathers data and documents test results
- Assist in qualification/validation of methods as needed
- Perform routine equipment maintenance and assist in troubleshooting as needed
- Accurately document and compare testing results against control/specification limits
- Initiate nonconformance reports for failing materials, Out-of-Spec investigations, Lab Investigations, Root Cause and CAPA related activities
- Create, revise and update standard operating procedures (SOP) as requested
- Mentor and train other quality control staff
- Perform routine and non-routine laboratory testing
- Data entry into manufacturing summary reports
- Perform data entry and peer review of quality documents for accuracy in accordance with laboratory procedures, standards and GMP requirements
- Perform advanced assays requiring precise analytical skills
- Perform testing and data analysis supporting DNA, RNA, protein and antibody sequencing projects
- Independently run all established QC assays
- Preparation of buffers along with pH adjustment
- Handling of product, including transfer of material for shipments of in-process samples and outsourced testing
- Maintain inventory of standards, reagents, and other lab consumables
- All employees are responsible for the general upkeep of work and shared spaces.
- Other duties as assigned.