GMP Analytical Data Integrity Specialist

Lever, Inc.; Bristol Township, Northern (Bucks County, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Abzena is seeking a highly skilled Analytical Services Contractor to support documentation and data review within analytical development. You will review notebooks, ensure GDP compliance, and support method validation, CoT generation, and GMP-related documentation for development batches.

The role requires expertise in HPLC, GC, CE-SDS, and strong familiarity with GDP and GMP standards, enabling cross-functional collaboration and timely data integrity checks.

Qualifications

• Bachelor’s degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 5+ years of industry experience in analytical development or quality control within GMP-regulated biopharmaceutical/pharmaceutical environments.
• Strong knowledge of separation-based analytical techniques (HPLC, GC, CE-SDS).
• Experience reviewing notebooks, technical reports, and GMP documents.

Responsibilities

• Review lab notebooks for GDP compliance, accuracy, and clarity of data.
• Provide technical support for separation-based assays (HPLC, GC, CE-SDS).
• Review analytical methods and ensure GMP compliance.
• Review qualification protocols/reports for methods transferred to QC for GMP manufacturing support.
• Assist in development reports and Certificates of Testing (CoT) generation for development batches.
• Ensure data and documentation meet regulatory and internal standards.

Skills

HPLC

GC

CE-SDS

GDP

GMP

Documentation

Data integrity

Cross-functional

Education

Bachelor’s degree in Chemistry or related

Tools

DMS

Job description

Abzena is seeking a highly skilled Analytical Services Contractor to support documentation and data review within analytical development. You will review notebooks, ensure GDP compliance, and support method validation, CoT generation, and GMP-related documentation for development batches.

The role requires expertise in HPLC, GC, CE-SDS, and strong familiarity with GDP and GMP standards, enabling cross-functional collaboration and timely data integrity checks.