QC Transfer & Validation Specialist II

Katalyst CRO; Portsmouth (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH is seeking a Quality Control Technical Transfer Analyst 3 to perform analytical testing, support technical transfers, and maintain quality documentation in a GMP-regulated environment. The role involves reviewing data, assisting with validations and investigations, ensuring Data Integrity, and collaborating with cross-functional teams.

You will use systems like LIMS, TrackWise, and Empower to document results and support continuous improvement.

Qualifications

• Hands-on analytical testing experience in a QC laboratory.
• Experience with method transfers, validations, and investigations.
• Familiarity with GMP and Data Integrity requirements.

Responsibilities

• Perform analytical testing for in-process samples, lot release, and stability studies.
• Support technical transfers, method validations, and laboratory investigations.
• Review analytical data and ensure results meet quality and compliance standards.
• Prepare and maintain quality documentation such as Deviations, CAPA, Change Control, and Investigations.
• Use laboratory systems and software including SoftmaxPro, Empower, SoloVPE, LIMS, and TrackWise.
• Support software validation activities, including writing procedures and executing validation test scripts.
• Apply GMP and Data Integrity principles in all laboratory activities.
• Collaborate with cross-functional teams and provide training when required.
• Perform root cause analysis for laboratory or software-related issues.

Skills

Analytical testing

Data review

Root cause analysis

Cross-functional collaboration

Training

Education

Associate's Degree in Life Sciences

Tools

SoftmaxPro

Empower

SoloVPE

LIMS

TrackWise

Job description

Katalyst CRO in Portsmouth, NH is seeking a Quality Control Technical Transfer Analyst 3 to perform analytical testing, support technical transfers, and maintain quality documentation in a GMP-regulated environment. The role involves reviewing data, assisting with validations and investigations, ensuring Data Integrity, and collaborating with cross-functional teams.

You will use systems like LIMS, TrackWise, and Empower to document results and support continuous improvement.