Using Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP), the Chemist will perform routine testing of raw materials, work-in-process materials, finished goods kits, and filled bottle components, as well as stability testing of on-market products. The QC chemist will be responsible for all aspects of laboratory operations, such as sample receipt, data generation, product verification, data analysis and summarization, out-of-specification investigations, instrument qualifications, and all other QC lab supporting activities.
- Conducts analytical and functional testing of raw materials, intermediates, finished goods kits and/or filled bottle reagents/calibrators according to approved SOPs.
- Perform testing using chemistry clinical analyzers and document accurate test results using spreadsheets and workbooks.
- Perform stability testing protocols on new launched products and on market products.
- Participate in daily standup meetings or scheduling meetings.
- Performs initial troubleshooting of issues which arise during routine analysis, perform out of specification OOS investigations and if needed, initiate non-conformance NCAR reports.
- Documents test results, complete batch records, document problems and other relevant information under cGMPs.
- Performs simple revisions and updates to SOPs as necessary and initiate procedure change orders.
- Summarize test data, maintain lot histories and analyze for trends and discrepancies.
- Maintain and order lab supplies as needed, and participate in lab clean ups.
- Participates in cross functional departmentl and team meetings.
- Performs other responsibilities to support the needs of the department as assigned by Supervisor.
- Participate in PPI, Lean, 5S programs.
- Minimum BS/BA in Chemistry, Biochemistry, or Bio-science 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 work independently.
- 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.