The Quality Assurance Associate II is responsible for maintaining all training of a QAA I in addition to the review of controlled documents (both executed and unexecuted) in accordance with applicable SOPs. The QA Associate II will document review activities and status in the applicable Quality Systems. The purpose of QA review is to ensure the document, product, or process under assessment is compliant with all TRC, customer, and regulatory agency requirements.

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
  • Manufacturing operations including supply chain, dispensing, compounding, filling, packaging, maintenance, and utilities
  • Quality operations including process control, quality control, quality assurance, compliance, and audit
  • Product labeling
• Track/trend the batch record review process- identify and initiate improvements to process
• 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
• Follow TRC SOPs, safety and health guidelines and cGMP guidelines

• Minimum of Associates degree with 1 year of relevant experience, Bachelors degree, or 3 years relevant experience
• Proficient with current word processing, spreadsheets, and database software
• A high level of integrity and attention to detail
• Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments
• Ability to handle and establish multiple priorities and meet expectations with minimal supervision
• Strong oral and written communication skills