Quality Assurance Associate - Product Release

Role Summary

Quality Assurance Associate – Product Release

Responsibilities

• Perform batch record review and audits, status notifications, assignment of stickering, serial file reviews and final disposition for manufactured in-process or final product release to ensure compliance to cGMPs/Outlines/Standards.
• Perform QA review/approval of executed records (Batch Records, Manufacturing Directions, Solution Records, Autoclave Records, Logbooks, QC Testing), Certificates of Analysis/Compliance for batch release and local SOPs, Test Specifications, Master Production Record Review, Special Outlines and Outlines of Production with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures/controls.
• Ensure product documentation is complete and compliant with specifications, SOPs, and regulations. Prepare, review and/or submit APHIS Form 2008‚Äôs against applicable Outlines of Production for USDA release.
• Review change management documentation, deviations, investigations and CAPA records for completion. Write new documents and revise existing QA documents as needed.
• Participate in and manage QA projects as needed with minimal supervision. Receive overall project direction from management but complete most work independently. Assist other Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.

Qualifications

• Bachelor‚Äôs degree in a scientific discipline (preferred) with 3+ years of quality experience.
• Technically self-sufficient and proficient in the performance of batch audits, product release, understanding of 9CFR and Form 2008 USDA submissions.
• Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU as related to manufacturing, quality, and release activities.
• Must be able to utilize all elements of the quality system to identify, classify, and control the status of finished products produced.

Skills

• Strong leadership, team building, organizational and interpersonal skills. High attention to detail.
• Demonstrated experience and proficiency with SAP, Veeva Vault, Microsoft Office (Word, Excel, PowerPoint, and Outlook).
• Excellent written and verbal communication skills with internal and external customers, peers, and managers. Excellent technical writing skills.
• Experience in quality and manufacturing of biological products (e.g., mAbs, recombinant proteins, vaccines).
• Experience in Operational Excellence, investigation procedures, materials management, and/or quality control testing for USDA or EU GMP regulated industries.

Education

• Not specified in the provided content beyond the bachelor‚Äôs degree requirement.

Additional Requirements

• None beyond those listed in Qualifications.