Job Title: Research Analyst
Position Overview: The Research Analyst (A-2) will conduct lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 under guidance from Group Leader and Senior Analysts. Conduct Bio-analysis validation and sample analysis with minimal supervision from experienced analyst(s). Review data, worksheets and reports for accuracy and timeliness. Document work and maintain study documentation and lab records. Perform other routine laboratory duties as deemed necessary. Maintain a safe environment. 1+ years working in a laboratory environment; regulated laboratory environment preferred.
- Bachelors degree in Chemistry or related field. M.S. preferred.
- Understand and comply with GLP requirements and follow Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies.
- Use and properly maintain lab instrument and equipment appropriately for assigned tasks.
- Conduct Bio-analysis validation and sample analysis with minimal supervision meeting company quality standards.
- Conduct method development under supervision.
- Prepare worksheets.
- QC the Plans, Methods and Reports.
- Data processing and table preparation (i.e. QC data and preparation, data integration, raw data printing, preparation of chromatograms for the report, use of LC-MS/MS, use of Watson LIMS, etc.)
- Maintain accurate records of work and study documentation per Good Documentation Practices as per company SOPs.
- Gain basic troubleshooting skills under the supervision of the Group Leader.
- Maintain clean and safe lab work environment.
- Participate in lab duties such as lab clean up, and instrument routine maintenance.
- Understand GLP requirements, SOP/SWPs and related lab procedures; safety policies and company policies.
- Use and maintain lab equipment appropriately for assigned tasks.
- Implement scientific theory with proper skills (i.e. LC-MS/MS, HPLC, MSD)
- Maintain quality execution and work.
- Ability to understand basic troubleshooting skills.