Senior Quality Control Analyst I – Data Review

Senior Quality Control Analyst I – Data Review Overview

• The Senior Quality Control Analyst I – Data Review will oversee analytical data review for gene therapy programs.
• Ensure compliance with cGMP standards and data integrity principles in all processes.
• Collaborate with internal and external stakeholders to resolve data discrepancies.
• Support regulatory inspections and internal audits with expertise in data review processes.
• Contribute to continuous improvement initiatives within the Quality Control department.
• Work in a dynamic, fast-paced environment with opportunities for professional growth.
• Participate in the development and implementation of standard operating procedures.
• Provide analytical documentation and support for product release activities.

Senior Quality Control Analyst I – Data Review Key Responsibilities & Duties

• Perform comprehensive reviews of cGMP analytical data packages for various testing methods.
• Verify data accuracy, completeness, and compliance with regulatory requirements.
• Assess analytical results for data integrity and adherence to ALCOA+ principles.
• Collaborate with stakeholders to resolve discrepancies and ensure timely data review.
• Generate and evaluate assay performance trends and data quality metrics.
• Support quality events, including deviations, investigations, CAPAs, and change controls.
• Author and revise SOPs, work instructions, and data review procedures.
• Provide subject matter expertise during regulatory inspections and audits.

Senior Quality Control Analyst I – Data Review Job Requirements

• Bachelor's or Master's degree in Cell Biology, Molecular Biology, Biochemistry, or related discipline.
• Minimum of 5 years of experience in a GMP/GLP environment; 7 years preferred.
• Extensive experience reviewing analytical data from molecular biology and bioassay methods.
• Proficiency with analytical techniques such as qPCR, ELISA, HPLC, and electrophoresis.
• Familiarity with electronic laboratory systems like LIMS, ELN, and SoftMax Pro.
• Strong understanding of cGMP regulations, FDA data integrity guidance, and quality systems.
• Excellent attention to detail and ability to identify discrepancies in data.
• Ability to work collaboratively in a fast-paced environment with strong communication skills.