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 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