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
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