GMP Data Reviewer – Analytical Services (Contract)

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

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.