Position Overview:
The QC Senior Analyst, Analytical Methods will support critical analytical method implementation workstreams in support of the facility start-up plan. These workstreams include analytical instrument qualification, critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Durham, North Carolina. The work schedule for this position will be based on the manufacturing production schedule The work schedule for this position will be based on the manufacturing production schedule and will primarily be split shift (12pm - 8pm) with the possibility of working weekends when needed.
Primary Responsibilities:
- Maintain and operate analytical instrumentation for flow cytometry and other bioassays.
- Analyze data; interpretation of data within given parameters.
- Investigate out of specification or unexpected results and study outcomes.
- Escalate and assist in the resolution of complex issues.
- Independently develop, author, and execute protocols, reports and other related documents.
- Communicate effectively with peers, and demonstrate collaboration across different functions.
- Support the implementation and execution of training programs and processes for less experienced QC Analysts.
- Draft and review technical documents.
Qualifications:
- Bachelor’s degree required, preferably in a life science discipline.
- 3+ years relevant experience.
- Advanced hands-on experience with various analytical techniques primarily flow cytometry.
- Scientific knowledge and direct experience with analytical method transfer requirements and processes.
- Advanced technical writing skills.
- Advanced problem-solving ability.
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize.
- work from multiple projects.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers.
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Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
- Ability to work 12 to 8 Monday through Friday and occasional weekends and holidays.
