QC Transfer & Method Validation Specialist

Katalyst CRO; Portsmouth (NH); On-site; USD 60,000 - 80,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH is seeking a Quality Control Analyst responsible for ensuring compliance with GMP and supporting laboratory operations. You'll conduct analytical testing, assist with method validations, and collaborate with cross-functional teams.

The ideal candidate will have experience with laboratory software and a strong understanding of Data Integrity principles. This role is crucial for maintaining product quality and regulatory adherence.

Qualifications

• Experience in analytical testing in pharmaceutical or biotechnology fields.
• Proficiency in GMP documentation and compliance.
• Familiarity with method transfers and validations.

Responsibilities

• Perform analytical testing for various laboratory samples.
• Execute methods according to GMP guidelines.
• Review laboratory data for accuracy.

Skills

Analytical testing

GMP compliance

Method validation

Data Integrity principles

Laboratory software utilization

Tools

LIMS

Empower

SoftMax Pro

SoloVPE

TrackWise

Job description

Katalyst CRO in Portsmouth, NH is seeking a Quality Control Analyst responsible for ensuring compliance with GMP and supporting laboratory operations. You'll conduct analytical testing, assist with method validations, and collaborate with cross-functional teams.

The ideal candidate will have experience with laboratory software and a strong understanding of Data Integrity principles. This role is crucial for maintaining product quality and regulatory adherence.