Quality Assurance Associate II

Overview

The Quality Assurance Associate II performs documentation activities associated with manufacturing operations while ensuring compliance with GXP quality systems.

Responsibilities

• Document Management
  • Electronic Document Management System (EDMS) workflow coordinator for GMP documentation and other GxP documentation, as needed
  • Document formatting and review
  • Attachment issuance support, that includes, but is not limited to, issuing and reconciling Batch Records, Solution Records and Validation Testing documentation and maintaining tracking tools, both hard copy and electronic
  • Assignment of raw material part numbers
  • Support raw material and product release
  • Label generation
  • Maintenance of label and ribbon inventory and scheduling annual maintenance of labeling machines
  • Write/revise QA SOPs and reports, as related to document control
  • Maintain, scan and archive Quality Assurance documentation
  • Report on Vendor Change Notifications to determine their effects, if any, on manufacturing
  • Responsible for organizing and maintaining off-site storage shipments for Fall River
• Training Program Support
  • Perform internal training, including, but not limited to, off-site storage preparation
  • Maintain training documentation including the hard copies and the electronic training files in SharePoint, as needed
  • Assist with the annual audit of training files
• Auditor
  • Conduct annual documentation audits
  • Support internal GMP audits
  • Support external audit documentation requests
• Other related job functions and QA support as needed

Qualifications

• Associate Degree with 2+ years GMP experience or 4+ years GMP experience without a degree
• Document Management experience in GMP environment preferred
• Broad knowledge of GMP and other GxP quality systems, policies, and regulations
• Strong communication and organizational skills
• Proficiency using MS Office Suite
• Proficiency using an EDMS
• The ability to multi-task and manage and prioritize workload in a proactive manner
• The ability to take initiative, maintain confidentiality, meet deadlines, and work independently and as part of a team

Compensation Statement