QC 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

Job Description

The Quality Control Technical Transfer Analyst 3 supports the QC department by performing analytical testing, assisting with technical transfer activities, and maintaining quality documentation in a GMP-regulated pharmaceutical or biotechnology environment. The role involves executing laboratory testing, reviewing data, supporting validations and investigations, and ensuring compliance with GMP and Data Integrity requirements.

Job Description

The Quality Control Technical Transfer Analyst 3 supports the QC department by performing analytical testing, assisting with technical transfer activities, and maintaining quality documentation in a GMP-regulated pharmaceutical or biotechnology environment. The role involves executing laboratory testing, reviewing data, supporting validations and investigations, and ensuring compliance with GMP and Data Integrity requirements.

Roles And 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.

Requirements

• 35 years of experience in a Quality Control laboratory within the pharmaceutical or biotechnology industry.
• Experience working in a GMP-regulated environment.
• Hands-on experience with analytical testing, method transfers, validations, and investigations.
• Experience with quality systems such as Deviations, CAPA, Change Control, and LIMS/TrackWise is preferred.
• Associate's Degree in Microbiology, Biochemistry, Biotechnology, Chemistry, or a related Life Sciences field.