Quality Control Analyst II - Molecular Biology

Tandym-Group; Woburn (MA); On-site; USD 55,000 - 78,000; Full time

Job summary

Tandym-Group is seeking a Quality Control Analyst II to join its Molecular Biology team in Woburn, MA. The role focuses on routine QC testing including ddPCR, dPCR, and qPCR to support in-process, release, and stability.

You will review cGMP analytical data, assist instrument qualification, and contribute to method transfer and validation activities for late-stage AAV-based programs, collaborating with internal and external stakeholders.

Qualifications

• 2+ years of related industry experience.
• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry.
• 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.

Responsibilities

• Perform routine QC testing including ddPCR, dPCR, and qPCR in-process, release, and stability.
• Review and approve cGMP analytical data for release and stability testing.
• Support QC Molecular Biology lab operations (instrument qualification, maintenance, reagents qualification).
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigations.

Skills

cGMP QC lab experience

Biochemistry knowledge

Team collaboration

Communication skills

Education

Bachelor's degree in Biochemistry/ Biology/ Chemistry

Master's degree in Biochemistry/ Biology/ Chemistry

Job description

Quality Control Analyst II - Molecular Biology (CR/511870) Woburn, Massachusetts

Salary: USD48 - USD48 per hour

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
• Workwith cross-functional teamswith both internal and external stakeholders
• Perform other duties, as needed

Qualifications

• 2+ years of related industryexperience
• 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