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 stability
Review and approval of cGMP analytical data for release and stability testing from internal and external analytical test methods
Support 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 needed
Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods
Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs
Author analytical method performance trend reports, as needed
Work with cross-functional teams with both internal and external stakeholders
Perform other duties, as needed
Qualifications:
2+ years of related industry experience
Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry
Bachelor's and/or Master's Degree n Biochemistry, Biology, Chemistry or a related discipline
Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution
Strong collaboration and team-working skills
Strong communication, interpersonal and organizational skills
Ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines

Quality Control Analyst II - Molecular Biology

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