Experienced in the use of multichannel pipette, cell work, and bioassay experience is required. Preferred experience in Growth Promotion Assay, Dot Blot, ELISA, cSDS methods, and/or HPLC/UPLC.
· In a team setting and cGMP environment, perform routine analytical testing in support of release and raw material samples. Conducts routine and non-routine testing of materials and product using a variety of equipment and test methods including but not limited to: HPLC testing, protein concentration testing, nephelometry testing, ELISA, cIEF, and SDS-PAGE. Prepare data and documentation using calculators and computer software.
· Entry and review of data in a Laboratory Information Management System (LIMS).
· Peer review, evaluate and investigate results from various analyses.
· Participate in special projects such as laboratory equipment validation, analytical method transfers and SOP reviews.
· Assist and train other chemists in everyday laboratory functions.
· Properly dispose of sample preparations and solutions according to safety and environmental procedures.
· Performs qualitative and quantitative chemical analysis of in-process manufacturing materials.
· Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry or related field.
· 0-4 years related experience in university/college or medical device, biopharmaceutical or pharmaceutical industry.
· Advanced knowledge/experience with regulatory requirements, policies and guidelines. Significant experience with Quality Control document reviews and regulatory inspection processes.
· Advanced knowledge of Quality systems.
· Coordinates testing responsibilities to ensure QC test support according to the needs of Manufacturing to maintain continuous process flow.
· Functions as a team member in the QC In Process Lab to provide timely test analysis information on the status of conformance to requirements.
· Investigates testing abnormalities and implements corrective action. Cross-trains in all testing responsibilities to ensure a fully cross-functional laboratory team environment.
· Maintains laboratory chemical supplies to ensure an adequate supply and prevent testing delays.
· Audits documentation, device history records, and test methods for compliance.
- Cell Work
- Multichannel Pipette