Position Overview:

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.

Primary Responsibilities:

• 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.

Qualifications:

• 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.