Quality Assurance Associate

About the role

The Quality Assurance Associate II maintains training for QAA I personnel and reviews controlled documents (both executed and unexecuted) in accordance with applicable SOPs. The role ensures compliance with TRC, customer, and regulatory agency requirements through documentation review activities tracked in applicable Quality Systems.

Responsibilities

• Batch record review for completeness, accuracy, and compliance to TRC standards
• Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)
• Track the number of corrections made in batch records
• Issue product Certificate of Analysis or Conformance
• Review of QMS documentation for compliance to SOPs, Work Instructions, and CGMP requirements
• Support manufacturing operations including supply chain, dispensing, compounding, filling, packaging, maintenance, and utilities
• Support quality operations including process control, quality control, quality assurance, compliance, and audit
• Product labeling review
• Track and trend the batch record review process to identify and initiate improvements
• Perform Product Complaint batch record review
• Maintain a professional, team-oriented working relationship with fellow employees
• Follow written and verbal procedures as directed by Supervisor
• Adhere to TRC SOPs, safety and health guidelines, and cGMP guidelines

Qualifications

• Minimum of Associate’s degree with 1 year of relevant experience, Bachelor’s degree, or 3 years of relevant experience
• Proficient with current word processing, spreadsheets, and database software
• High level of integrity and attention to detail
• Ability to work independently and contribute to a team-oriented environment by developing positive working relationships across departments
• Ability to handle and establish multiple priorities with minimal supervision
• Strong oral and written communication skills