22 Apr
Contract Quality Control Analyst
Vacancy expired!
- Generate compliant laboratory data for release, assessment of stability, validation of assays, and support of process development. Perform assays and techniques involving HPLC, capillary electrophoresis, ELISA, qPCR, and/or other protein analytical technologies, executing all of the techniques used in the department with equal proficiency.
- Participates in assay qualifications.
- Assist with training new analysts.
- Perform biennial SOP reviews and make needed revisions.
- Peer-review documentation and results from other analysts for completeness.
- Order supplies, clean equipment, organize common areas and stocks.
- Initiate and participate in laboratory investigations.
- Minimum of 3-5 years working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
- Exhibits understanding of the principles, concepts, and practices in QC testing of biopharmaceuticals.
- Hands-on experience in HPLC, capillary electrophoresis, ELISA, and gel-based assays for analysis of recombinant proteins.
- Experience working under cGMP regulations and with ICH/FDA/EMA guidelines.
- Ability to identify and investigate assay and equipment problems.
- Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
Vacancy expired!