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Job Description:

We are seeking a Quality Control Technical Transfer Analyst 3 to join our Quality Control team. This role supports production by contributing to technical transfer activities and ensuring high-quality testing for in-process materials, final products, and stability studies. The ideal candidate is detail-oriented, highly organized, and experienced in laboratory testing and documentation within a regulated environment.

Key Responsibilities

  • Perform testing for In-Process, Lot Release, and Stability studies.
  • Conduct testing for investigations, transfers, and validations.
  • Review assay results and ensure data integrity compliance.
  • Write and manage Quality Records (Deviations, CAPA, Change Control) and Test Methods.
  • Support method transfers, new instrument implementation, and method qualifications.
  • Train team members on quality control processes and laboratory techniques.
  • Utilize Microsoft Office Suite (Word, Excel, PowerPoint) and laboratory computer systems.
  • Work within GMP Quality Systems such as TrackWise and LIMS.
  • Identify deviations from standard procedures and escalate as needed.
  • Apply Data Integrity principles and ensure compliance with company policies.
  • Participate in problem-solving, prioritization, and project planning efforts.
  • Maintain a positive and team-oriented attitude, contributing to a collaborative work environment.

Requirements:

  • Associate’s Degree (or higher) in Microbiology, Biochemistry, or a related scientific field.
  • Experience in a GMP-regulated laboratory or manufacturing environment is preferred.
  • Strong public speaking and communication skills (both verbal and written).
  • Ability to interpret data independently or with guidance.
  • Strong problem-solving skills and ability to prioritize tasks effectively.
  • Proficiency in quality systems, laboratory software, and data integrity principles.
  • Self-motivated team player with a commitment to accuracy and quality.
  • Ability to work full assigned shifts, including timely arrival and task completion.