About this role
Job Description:
We are seeking a highly skilled, passionate, and motivated scientist to join our Quality Control (QC) Operations and Metrology team to support day-to-day operations of the QC Laboratory. This role will support equipment qualification/calibrations, manage vendors, and assist with building out further organizational tools for the QC Laboratory. The position will be part of a technical operations team that aims to advance preclinical gene editing candidates into the clinic and works closely with IT, Operations, and internal/external quality control groups.
Key Responsibilities:
Support the Quality Control Team/Lab and ensure that all state-of-the-art equipment is qualified, calibrated, and functioning to the expectations of the lab.Manage working relationships with various third-party equipment vendors. Schedule future calibrations and preventative maintenance for equipment within the QC Lab.Identify key consumables and supplies within QC Lab and maintain stock as needed.Maintain/organize all documentation generated for equipment/samples.Summarize results in presentations and technical reports.Track and trend temperature data for all controlled temperature storage units.Author and review equipment qualification reports, protocols, and other quality system documentation.Other duties as assigned.Leadership Responsibilities:
Supports and monitors the performance of the team of employeesMay participate in new hire interviewsSupports the on-boarding process of new employeesDisseminate administrative communicationsDemonstrate and promote the company's visionEnsure adherence to highest quality and efficiency standards in laboratory operationsEnsure coverage and performance for all shifts, and work dutiesPerforms administrative tasks for team member growth and developmentAdeptly balance technical lab work with leadership responsibilitiesFoster morale and teamwork Minimum Required Qualifications:
B.S. in Chemistry, Biology, or related field with 4-6 years of relevant experience.Proficiency with Good Documentation Practices in a cGMP-regulated environment.Demonstrated experience in equipment calibration and qualification activities (IQ/OQ/PQ) and laboratory inventory managementHands-on experience with instrumentation including PCR, ELLA, Fragment Analyzer, lab freezers and refrigerators, biosafety cabinets, incubators, cell counters, and pipettes.Experience with LIMS, or other data management systems, and GxP Computer systems.Experience authoring, reviewing and approving documents in Electronic Document Management Systems.Proven ability to manage multiple priorities and work independently.Thorough attention to detail with the ability to critically analyze ideas, data, and reports.Strong communication skills and customer-centric approach when coordinating with scientists, vendors, and service providers.Proactive mindset with the ability to take initiative, solve problems, and drive tasks to completion.Preferred Qualifications:
Background in quality assurance.Laboratory supervisor experience.Knowledge and understanding of ICH guidelines and FDA/EMA regulations.Knowledge of operational excellence and process improvement tools and methodologies including Lean and Six Sigma.Authorization to work in the United States indefinitely without restriction or sponsorship. Position is Full Time, Monday-Friday, 8am-5 pm. Candidates currently living within a commutable distance of Boston, MA are encouraged to apply
Excellent full-time benefits include:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidayYearly goal-based bonus & eligibility for merit-based increasesCompensation: $45.00-$48.00 per hour based on education and experienceEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.