You will be required to use standard operating procedures and good manufacturing practices to conduct routine and non-routine testing and analysis of incoming raw materials, work-in-process materials, and/or matched kits and filled bottle reagents. You may be asked to participate in projects for troubleshooting, process improvement, and new product transfer.
Performs routine analysis of raw materials, intermediates, and/or matched kits and filled bottle reagents according to approved SOPs.
Performs initial review on departmental paperwork; completed batch records
Maintains and analyzes lot histories for trends and discrepancies
Initiates NCARs, CAPAs, Deviations when appropriate
Performs initial troubleshooting of issues which arise during routine analysis.
Documents test results, problems and other relevant information under cGMPs.
Performs simple revisions and updates to SOPs as necessary.
Participates in interdepartmental meetings.
Performs other responsibilities to support the needs of the department as assigned by Supervisor.
Acts independently to determine methods and procedures on new assignments.
Keeps department lead or supervisors updated on all issue
Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry. Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree. Strong laboratory skills including pipetting, safety, and hazardous chemical handling. Understanding of cGMP and how it applies to the work environment is preferred. High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear, understandable documentation. High level of verbal communication skills. Manual dexterity, must be able to lift/move up to 20 pounds. Intermediate word processing and spreadsheet software skills. Ability to manage multiple tasks simultaneously. Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.
Thermo Fisher Scientific - 22 months ago
Thermo Fisher Scientific’s 50,000 employees share a single mission: to enable our customers to make the world healthier, cleaner and...