Position Title – Quality Control Specialist 1 Data Analysis
Location– Carlsbad, CA
Shift –Monday to Friday 9 am-5:30 pm
Pay Rate – $32 an Hour
Job Description:
- Supports routine and non-routine analysis, including but not limited to biochemical and chemical analysis, of raw materials, in-process items and finished product according to established operating procedures.
- Compiles data for documentation of test procedures that may include stability program testing and formulation studies. Calibrates and maintains lab and analytical equipment. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed.
- May perform special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
- This position conducts signal data analysis for tested products under minimal guidance. This position also investigates, troubleshoots and documents out of trend data discovered during signal analysis.
Experience Requirements
- Follows cGMP and ISO standards or guidelines as they apply to manufacturing • Performs data analysis under minimal guidance and communicates these results to the supervisor and coordinating departments
- Investigates, troubleshoots and documents out of trend signals discovered during data analysis under minimal supervision
- Works closely with technical and operational subject matter experts to understand processes and to perform root cause analysis on data issues
- Completes batch records while maintaining good documentation practices
- Prepares/formulates QC test solutions as needed following standard operating procedures and guidelines given by supervisor; solutions include aqueous solutions containing salts, organics, acids, bases and/or modified DNA and organic solutions • Performs laboratory tests on incoming raw materials, in-process samples, and final product samples before distribution as needed following standard operating procedures
- Participates in departmental projects—work with QC, QA and PTS on OOS and NCR investigations as needed • Understanding of molecular techniques (DNA extraction, PCR Amplification) Education and Experience
- B.S. degree required, in basic sciences, life sciences, or engineering and/or 3 years of relevant experience in a QC capacity.