The QC Senior Analyst will support critical analytical method implementation workstreams in support of the laboratory 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 Cambridge, Massachusetts.
- Contribute to setup of the QC laboratory including instrument purchasing, IQ/OQ/PQ, and operation SOPs.
- Collaborate with multiple departments to setup BMS, CMMS, validation software, LIMS and system SOPs for the QC laboratory.
- Maintain and operate analytical instrumentation for a variety of analytical methods.
- 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.
- Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors.
- Support stability data analysis along with stability document reviews.
- Managing and ordering of laboratory reagents and materials.
- General cleaning and upkeep of the laboratory.
- Bachelor’s degree required, preferably in a life science discipline.
- 5+ years relevant experience.
- Advanced hands-on experience with various analytical techniques including bioassays, flow cytometry, sequencing, PCR, Mass spec.
- 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.