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Data Reviewer II at AllSTEM Connections Data Reviewer II at AllSTEM Connections in GLENMONT, New York Posted in 1 day ago.

Type:

full-time

Job Title:

Data Reviewer II Location:

Albany NY Duration:

6+ Months 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

Responsibilities:

Responsibilities

• Review quality control testing for compliance with internal SOPs and specifications
• Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as 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.