Data Reviewer, Analytical Services

AL Solutions; Philadelphia (Philadelphia County); On-site; USD 55,000 - 76,000; Full time

Benefits offered by this job

On-site in Philadelphia, PA

Job summary

AL Solutions is seeking a Data Reviewer for Analytical Services on a contractual basis in Philadelphia. The role focuses on reviewing analytical data for tech transfer, GMP release, and stability programs, ensuring accuracy, compliance, and data integrity.

The ideal candidate has 5+ years in a cGMP environment with 3+ years in data review, and familiarity with HPLC/GC/CE-SDS. On-site availability in Philadelphia is required.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Chemical Engineering, or related scientific discipline.
• 5+ years in a cGMP analytical laboratory environment.
• 3+ years of analytical data review or quality data analysis experience.
• Strong understanding of separation-based techniques (HPLC/GC/CE-SDS).
• Knowledge of cGMP, GDP, and data integrity principles.
• Excellent attention to detail and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to manage multiple assignments under tight timelines.

Responsibilities

• Review and approve cGMP analytical data against specifications, SOPs, protocols, and standards.
• Support technology transfer, product release, and stability testing activities.
• Assess results for accuracy, completeness, compliance, and scientific validity.
• Identify data/documentation discrepancies and coordinate resolution with lab teams.
• Review laboratory investigations and support resolution of quality issues.
• Support product release activities and help meet project timelines.
• Review analytical trends and contribute to stability and performance reporting.
• Promote data integrity and a right-first-time approach across laboratory operations.
• Create and revise SOPs, test forms, and other controlled documents.
• Collaborate with Quality Control and cross-functional teams.
• Provide timely progress updates to management.

Skills

cGMP analytical lab

data review

HPLC

GC

CE-SDS

data integrity

communication

prioritization

problem solving

Education

Bachelor's degree in Chemistry, Biology, Chemical Engineering, or related scientific discipline

Tools

Empower

LC-MS (preferred)

Job description

Data Reviewer, Analytical Services | Contract | $40-$55 per hour | On-Site in Philadelphia

George Higginson is currently partnered with a leading biologics CDMO looking to hire an experienced Data Reviewer within its Analytical Services team.

This contract position will focus on reviewing analytical data generated in support of technology transfer, GMP product release, and stability programs. The Data Reviewer will ensure that results are accurate, scientifically sound, and compliant with internal procedures, customer specifications, and cGMP requirements.

Responsibilities:

• Review and approve cGMP analytical data against specifications, SOPs, protocols, and established standards
• Support Analytical Services activities related to technology transfer, product release, and stability testing
• Assess analytical results for accuracy, completeness, compliance, and scientific validity
• Identify data or documentation discrepancies and work with laboratory teams to resolve them promptly
• Review laboratory investigations and support the resolution of quality issues
• Support product release activities and help ensure project timelines are achieved
• Review analytical trends and contribute to stability and performance reporting
• Promote data integrity and a right-first-time approach across laboratory operations
• Create and revise SOPs, test forms, and other controlled documents
• Collaborate with Quality Control and cross-functional project teams
• Provide timely progress updates to management

Requirements:

• Bachelor’s degree in Chemistry, Biology, Chemical Engineering, or a related scientific discipline
• 5+ years of experience in a cGMP analytical laboratory environment
• 3+ years of analytical data review or quality data analysis experience
• Strong understanding of separation-based analytical techniques, including HPLC, GC, or CE-SDS
• Experience reviewing analytical data for compliance with specifications, procedures, and regulatory requirements
• Strong knowledge of cGMP, Good Documentation Practices, and data integrity principles
• Excellent attention to detail and scientific problem-solving skills
• Ability to prioritize multiple assignments and work within demanding timelines
• Strong written and verbal communication skills

Preferred Experience:

• Working knowledge of HPLC, UPLC, or LC-MS
• Experience using Empower
• Experience reviewing stability testing data
• Familiarity with ICH stability, analytical method validation, and impurity guidelines
• Experience with analytical data trending, specification setting, or the interpretation of development and stability data
• Previous experience within a biologics, pharmaceutical, or CDMO organization
• $40-$55 per hour, depending on experience
• On-site position in Philadelphia, PA
• Analytical Services-focused data review role
• Opportunity to support GMP release, stability, and technology transfer programs within a growing biologics organization