Research Analyst ※US Office
The Research Analyst will perform lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts. Conduct Bio-analysis validation and sample analysis independently. Conduct Pre-Study with minimal supervision. Utilize establish techniques to compile and analyze data. Document work and maintain study documentation and lab records. Provide direction and technical assistance to lesser-skilled team members. Assist with SOP/SWP preparation and other technical related documents including client communications. Perform other routine laboratory duties as deemed necessary
- 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 independently meeting company quality standards.
- Conduct pre-study method development with minimal supervision.
- Assist Group Leader with Plan and Report preparation.
- Maintain accurate records of work and study documentation per Good Documentation Practices as per company SOPs.
- Proficient troubleshooting skills.
- Maintain clean and safe lab work environment.
- Assist with SOP/SWP preparation and other technical related documents.
- Attend and participate in trainings, project meetings, etc.
- Contribute to a cohesive team environment. Communicate effectively with management, other units, coworkers and clients.
- Participate in lab duties such as lab clean up, and instrument routine maintenance.
- Maintain proprietary and confidential information.
- Assumes other activities and responsibilities as assigned.
• 2+ years working in regulated laboratory environment; GLP BioA Lab highly preferred.
• B.S. in related field (i.e. Chemistry, Biochemistry), M.S. preferred, or Equivalent.
Experience and Skills
• Understand GLP requirements, SOP/SWPs and related lab procedures; safety policies and company policies.
• Use and maintain lab equipment appropriately for assigned tasks.
• Utilize scientific theory with proper skills (i.e. LC-MS/MS, HPLC, MSD)
• Maintain quality execution and work.
• Proficient troubleshooting skills.
• Ability to handle confidential information.
• Demonstrated effective oral and written communication skills.
• Good team player.
• Effective time management skills; complete work in a timely manner (i.e. maintain
• Proficient in MS Office and to be adept at learning new systems.