QA Associate II

The Quality Assurance Associate II is responsible for maintaining all training of a QAA I in addition to the review of controlled documents 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, client, and regulatory agency requirements.

Responsibilities:

• Batch record review for completeness, accuracy, and compliance to TRC standards and coordinate required corrections
• Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)
• Escalate deviations and other issues impacting quality to Management and the affected department
• Issue product Certificate of Analysis or Conformance
• 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
• Copy / Scan batch records and QMS documentation
• Follow TRC SOPs, safety and health guidelines and cGMP guidelines

Levels:

• New Hire (level 1): Complete initial training and review level 1 batch records.
• Experienced (level 2): Complete all training and review level 1 and 2 batch records. Able to perform batch release.
• Senior (level 3): Perform all above requirements. Able to review executed Validation & Development batches as well as create/revise QA SOPs and Work Instructions.

Qualifications:

• Minimum of Associates degree with 1 year of relevant experience, Bachelor 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