QA Specialist II

Role Overview

The QA Release Specialist II reviews and evaluates batch documentation and testing records to ensure compliance with cGMP and regulatory requirements, and identifies and escalates quality issues to support material disposition and final batch release.

Responsibilities

• Review and evaluate executed batch documentation, production records, testing records, and supporting data for completeness, accuracy, and compliance with cGMP, cGDP, approved procedures, and applicable regulatory requirements.
• Evaluate documentation and supporting evidence to determine whether Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and other established requirements have been met to support material disposition and final batch release.
• Identify and escalate quality issues that may impact product quality, patient safety, regulatory compliance, or batch disposition, ensuring deviations and other quality events impacting release are appropriately investigated and resolved.
• Serve as a QA subject matter expert in the review and disposition of materials and products, including final batch release, while managing multiple review activities and established timelines.
• Collaborate with cross-functional partners, including Quality Assurance, Quality Control, Operations, Manufacturing, and other supporting functions, to facilitate documentation review, correction, finalization, and disposition activities.
• Support continuous improvement by tracking and trending documentation errors, providing task-specific training, and contributing to the development or refinement of work instructions, training materials, procedures, and other quality documentation.

Essential Requirements

• A minimum of one (1) year of experience in a Quality or auditing role within a regulated or GMP-compliant environment.
• Bachelor of Science degree preferred, with a life science discipline preferred, or equivalent work experience.
• Effective communication, critical thinking, and decision-making skills, with the ability to work independently and collaboratively, evaluate potential risks to product quality or regulatory compliance, manage multiple priorities, and meet established timelines.

Preferred Experience

• Any relevant experience in validation processes, procedures, and concepts.
• US Code of Federal Regulations (CFR) and/or EU Regulations cGMP, GMP, manufacturing and related equipment, QC testing and related equipment.