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Jobs · Quality Assurance · Texas

Quality Control Analyst II, Cell Therapy (PM Shift)

Lonza · Houston, TX · Yesterday
Quality AssuranceFull-time

The Role

The QC Analyst II, Cell Therapy (PM Shift) is responsible for performing Quality Control assays for product release of cell therapy products, Raw Material Release and Stability Studies. Duties include maintaining data and adhering to cGMP regulations, including writing deviations and other Quality documentation.

Responsibilities

  • Use extensive knowledge of defined SOPs & policies to make sound decisions.
  • Record test results and maintain raw data accurately.
  • Effectively present information and ideas, facilitating understanding among team members.
  • Provide constructive suggestions for improving documentation and workflows.
  • Support the development of others through mentoring and training.

Requirements

  • Demonstrated knowledge in biological, cell-based assays, including flow cytometry.
  • Demonstrated ability to complete methods/procedures and operate specialized lab equipment.
  • Perform tasks with strict adherence to cGMP and cGDP principles.
  • Capable of maintaining and troubleshooting basic and specialized lab equipment.
  • In-depth understanding of cGMP principles, with the ability to identify breaches and suggest corrective actions.
  • Developing Subject Matter Expertise, recognized as a reliable information source by less experienced analysts.
  • Proficient in using spreadsheets, databases, and word processing software.
  • Bachelor's degree in a relevant science field.

Qualifications

Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO).

Benefits

  • Performance-related bonus.
  • Medical, dental and vision insurance.
  • 401(k) matching plan.
  • Life insurance, as well as short-term and long-term disability insurance.
  • Employee assistance programs.
  • Paid time off (PTO).

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

Available shift: 4:00 PM - 2:30 AM to ensure continuous quality control support. Shift differentials included for night shift and weekends.

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