About The Position

Within the Analytical Service team, this role is part of a functional service provider solution that allows customers to leverage staff experience while providing the employee with direct onsite experience at a pharmaceutical or biopharmaceutical company. The QC Operations Analyst joins the Cell and Gene Therapy Department to support quality control operations in a fast-paced GMP environment. The candidate must be flexible to work in Boston or Cambridge depending on business needs. The position is temporary and is offered through a third-party agency partner for assignment at Vertex Pharmaceuticals. Candidates will train Monday through Friday before transitioning to a Sunday–Wednesday shift. During manufacturing runs, the schedule may shift later, with a later start time. The listed shift is 12:30 PM–11:00 PM, with a manufacturing-run schedule of 3:30 PM–2:00 AM at least twice a month. The role is eligible for overtime pay in accordance with federal and state requirements. The pay range is $40–$43 per hour; the agency partner will provide compensation, medical benefits, fringe benefits, and other employment terms upon offer.

Requirements

  • Bachelor's degree in Chemical Engineering, a scientific field, or an equivalent relevant formal academic or vocational qualification.
  • Ability to understand and independently apply GMPs and/or GLPs in everyday work, including documentation and instrument use.
  • Proficiency in Microsoft Excel and Word.
  • Problem-solving and troubleshooting abilities.
  • Good written and oral communication skills.
  • Time-management and project-management skills.
  • Ability to work collaboratively in a team environment.
  • Ability to lift and move objects up to 25 pounds.
  • Flexibility to work at Boston or Cambridge depending on need.
  • Flexibility to work the designated shift schedule, including later hours during manufacturing runs.

Nice To Haves

  • Previous GMP laboratory experience; 0–2 years of industry experience is noted as preferred.
  • GMP experience.
  • LIMS experience.

Responsibilities

  • Work cross-functionally with internal facility, validation, and metrology teams and external CTL and instrument vendor teams to minimize interruptions to day-to-day laboratory operations.
  • Identify and create processes that support success in the QC laboratory.
  • Manage sample, reagent, and chemical lifecycles.
  • Establish, write, and update Standard Operating Procedures (SOPs) as needed to support QC operations and comply with GMP guidelines.
  • Set up and maintain instrumentation in collaboration with QC, QA, facility, and vendor teams.
  • Maintain QC equipment and perform regular performance verification or calibration as specified by equipment SOPs.
  • Communicate project status to the project leader.
  • Perform work assignments accurately, promptly, and safely.

Benefits

  • Overtime pay in accordance with federal and state requirements
  • Medical benefits and fringe benefits are provided through the third-party agency partner, with terms presented upon offer.
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