QC Technical Transfer 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

Job Summary

The Quality Control Analyst supports laboratory operations by performing analytical testing, reviewing laboratory data, supporting method transfers and validation activities, and ensuring compliance with GMP and Data Integrity requirements. This role works within a pharmaceutical or biotechnology quality control laboratory and collaborates with cross-functional teams to support product quality and regulatory compliance.

Responsibilities

• Perform analytical testing for raw materials, in-process samples, finished products, stability samples, and lot release testing.
• Execute analytical methods following GMP guidelines.
• Support analytical method transfers between laboratories.
• Assist in method validation and verification activities.
• Review laboratory data for accuracy and completeness.
• Investigate laboratory deviations and Out-of-Specification (OOS) results.
• Prepare and maintain GMP documentation.
• Support Change Controls, CAPAs, Deviations, and Investigations.
• Perform root cause analysis and implement corrective actions.
• Maintain laboratory instruments and equipment.
• Utilize laboratory software including LIMS, Empower, SoftMax Pro, SoloVPE, and TrackWise.
• Support software validation and CSV activities.
• Ensure compliance with cGMP, GDP, ALCOA+, and Data Integrity principles.
• Participate in audits and inspection readiness.
• Collaborate with QA, Manufacturing, Validation, and Engineering teams.
• Train laboratory personnel on procedures and systems when required.