Job Description

This role is a Quality Control (QC) Document Reviewer focused on bioassay testing in a Good Manufacturing Practice (GMP) laboratory setting. The primary responsibilities involve reviewing executed test records, audit trails, reagent logs, and equipment logbooks to ensure compliance with regulatory and internal quality standards.

Key Aspects of the Role:

Review & Compliance

• Examine molecular and cell-based assay test records for accuracy and adherence to standards.
• Ensure compliance with Good Documentation Practices (GDP) and Data Integrity requirements.
• Follow GxP regulations (Good Laboratory/Manufacturing Practices).

Laboratory Documentation & Systems

• Review audit trails and maintain compliance documentation.
• Utilize Labvantage LIMS (Laboratory Information Management System) and LES (Laboratory Execution System) for data management.
• Verify reagent logs and equipment usage records.

1. Training & Process Adherence

• Follow Standard Operating Procedures (SOPs) and work instructions precisely.
• Maintain training and qualifications on schedule.

Requirements & Preferred Skills:

• Education & Experience:
• Bachelor’s degree in a STEM field.
• 5+ years of experience in a GMP laboratory with hands-on work in molecular biology and cell-based assays (e.g., qPCR, sequencing, potency testing, mammalian/bacterial cell culture).
• Experience reviewing GMP data and audit trails.
• Preferred Skills:
• Familiarity with USP, ISO, FDA, and ICH guidelines.
• Strong knowledge of data integrity principles and GDP.
• Effective communication and collaboration skills.

Schedule & Work Environment:

• On-site role (not remote).
• Shift: Monday–Friday, 11 AM – 7 PM.
• Requires strong attention to detail, regulatory compliance, and the ability to work in a structured laboratory environment.

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