Quality Control Analyst II - Molecular Biology

A pharma company in Massachusetts is looking to add a new Quality Control Analyst II to join their Molecular Biology team. Responsibilities:Perform routine QC testing including but not limited to: ddPCR, dPCR, and qPCR test methods in support of in-process, release, and stabilityReview and approval of cGMP analytical data for release and stability testing from internal and external analytical test methodsSupport the QC Molecular Biology laboratory operations (ex. Instrument qualification and maintenance, housekeeping, qualify critical reagents, etc.)Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as neededWrite, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methodsSupport method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programsAuthor analytical method performance trend reports, as neededWork with cross-functional teams with both internal and external stakeholdersPerform other duties, as needed Qualifications:2+ years of related industry experienceExperience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industryBachelor's and/or Master's Degree n Biochemistry, Biology, Chemistry or a related disciplineHands-on experience with performing dPCR, ddPCR and/or qPCR test method executionStrong collaboration and team-working skillsStrong communication, interpersonal and organizational skillsAbility to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines