QA Documentation Associate II

QA Documentation Associate II coordinates review and approval of GMP documentation using electronic systems. The role manages master batch records, protocols, and specifications while supporting document control processes and administrative tasks for a pharmaceutical services company.

Responsibilities

• Coordinate document review and approval workflows within electronic management systems
• Revise and process master batch records for changes, corrective actions, and errors
• Monitor QA and QC databases for documentation trending and maintenance
• Issue batch records, laboratory notebooks, and logbooks for production and testing
• Track document errors and maintain archival records per retention policies

Requirements

• High school diploma or equivalent; associate degree preferred
• 2-4 years experience in documentation, quality assurance, or related field
• Familiarity with cGMP guidelines
• Proficiency with Microsoft Office and data entry systems
• Strong written and verbal communication skills
• Detail-oriented with ability to work independently or collaboratively

Compensation: $24.08-$27.09 per hour plus annual performance bonus eligibility