Job Details

  • Title: Quality Assurance Associate
  • Code: RCI-03452
  • Location: Waltham Massachusetts (MA) 02451
  • Posted Date: 01/11/2021
  • Duration: 6 Months
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  Job Description

This position will be 100% remote for the life of the contract (6months)
Quality Assurance professional preferably with experience with contract manufacturers.
Core Responsibilities
• Release product in accordance with approved specifications and procedures.
• Monitor contractor compliance via GxP documentation review and on-site visits/audits.
• Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.
• Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
• Interact with multi-functional internal and external project teams to ensure compliance.
• Respond to technical and quality issues and handle schedule and/or process-related conflicts.
• Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (biologics).
• Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.

Additional Responsibilities
• Provide QA project manager support for change controls and other projects.
• Support program for maintaining performance metrics.

The QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with relevant quality standards, relevant regulatory councils, and other regulatory requirements and perform administrative tasks.. Years of Experience: 6 - 9 Years