Quality Assurance Data Reviewer

Overview

The Quality Assurance Data Reviewer is essential to maintaining compliance with current Good Manufacturing Practices (cGMP) standards and regulatory requirements within the laboratory environment. This role is pivotal in supporting the integrity of testing processes, ensuring data accuracy, and upholding overall quality assurance in the contract laboratory environment.

• Review of analytical records generated during testing of API, finished product, in-process, and stability for compliance with current Good Manufacturing Practices (cGMP), internal procedures, and USP guidelines.
• Review method validation and verification data.
• Ensure compendial updates / changes are implemented.
• Ensure compliance for all analytical activities.
• Ensure compliance with good documentation practices and verify calculations, appropriate test methods/specifications applied to sample testing.
• Review analytical data for accuracy, completeness, and FDA compliance. Data includes lab notebooks, logbooks, chromatography, and electronic data/audit trails.
• Apply technical and regulatory knowledge and judgement to review experimental data for compliance with internal SOPs and quality standards with minimal supervision.
• Review and approval of controlled documents such as SOPs, protocols, test methods, and specifications.
• Reviews internal and external documents such as Deviation, Out of Specification (OOS) Investigations, CAPAs, and Quality Protocols, as necessary.
• Support the SOP revision process by communicating with concerned departments.
• Support in FDA or customer/client/in-house audits as needed.
• Communicate within and with other departments about timelines and any quality issues/observations.
• Trending of purified water test results.
• Handling of stability samples.
• Review and calculation of Mean Kinetic Temperature (MKT) of warehouse and stability chambers data.
• Participate in GMP, departmental, and company-wide training as necessary.
• Maintain a track and status of documents and data packages submitted for review.
• Communicate with analytical scientists, supervisors, and management on technical issues, investigations, and process improvements.
• Perform other functions as required or assigned.

• Education: Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, or related field
• Experience: 5+ years’ experience in a cGMP environment, preferably in the pharmaceutical industry, with a cGMP environment in Quality Control and/or Analytical R&D department is required
• Extremely strong organizational, project management, communication, analytical, and Excel/Word/PowerPoint skills.
• Strong communication skills, both written and verbal

BENEFITS:
Offers a comprehensive benefits package to employees