GMP QC Operations Analyst (Cell & Gene Lab)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 55,000 - 59,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a QC Operations Analyst to support QC operations in a fast-paced GMP environment within the Cell and Gene Therapy Department. The role requires GMP lab experience and strong organizational skills, with potential shifts rotating including Sun-Wed schedules in Boston/Cambridge.

The position involves cross-functional collaboration with facility, validation, metrology, and vendors, plus SOP creation, instrument setup, calibration, and timely project communications.

Qualifications

• Bachelor's degree in Chemical Engineering, Scientific Field, or equivalent and relevant formal academic / vocational qualification.
• GMP lab experience preferred (0-2 years industry experience).
• An equivalency consisting of education, training and/or related experience may be considered.

Responsibilities

• Work cross functionally with internal (facility, validation, metrology) and external (CTL, instrument vendors) teams to minimize day to day lab operations interruptions
• Identifying and creating processes that will ensure success within the QC lab
• Sample, reagent and chemical lifecycle management
• Establish, write, and update Standard Operating Procedures (SOPs) in GMP guidelines as needed in support of quality control operations
• Sets up and maintains instrumentation by working with the cross functional team (QC, QA, facility and vendors)
• Maintain QC equipment and perform regular calibration as specified by equipment SOP
• Communicates project status to project leader
• Performs work assignments accurately, and in a timely and safe manner
• Shift work applies - 2 roles: Sun – Wed 12:30 PM – 11:00 PM; 3:30 PM – 2:00 AM (manufacturing run) at least 2x a month

Skills

GMP lab experience

Microsoft Excel

Microsoft Word

Communication skills

Time management

Project management

Team collaboration

Physical lifting 25 pounds

Education

Bachelor's degree in Chemical Engineering or related field

Tools

LIMS

Job description

Vertex Pharmaceuticals is seeking a QC Operations Analyst to support QC operations in a fast-paced GMP environment within the Cell and Gene Therapy Department. The role requires GMP lab experience and strong organizational skills, with potential shifts rotating including Sun-Wed schedules in Boston/Cambridge.

The position involves cross-functional collaboration with facility, validation, metrology, and vendors, plus SOP creation, instrument setup, calibration, and timely project communications.