Data Reviewer II

Responsibilities

• Review quality control testing for compliance with internal SOPs and specifications
• Aid in technical data review of raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity
• Collaborate with lab personnel for data review per cGMP compliance, data integrity
• Ensure all tests are per cGMP compliance and in compliance with the company’s standard operating procedures
• Provide training to new hires as needed
• Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
• Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
• Provide support on Raw Material release and GMP production suite commissioning activities when necessary
• May perform QA cleaning verification and inspection activities when required
• Other duties as assigned

Qualifications

• Bachelor’s Degree in Chemistry or related field and a minimum of three years’ relevant industry experience; OR Master’s degree and one-year relevant experience
• Preferred Experience working in cGMP or GLP pharmaceutical industry environment
• Other Qualifications: Must pass a background check, Must pass a drug screen, May be required to pass Occupational Health Screening