Quality Assurance Associate

Job Description :

This position will provide support to ensure the organization maintains compliance with Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practices (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards. This individual will perform a variety of activities needed to establish and maintain compliance; including responsibilities associated with the quality assurance tasks.

Responsibilities :

• Perform job functions in compliance with internal Standard Operating Procedures, Current Good Manufacturing and Tissues Practices, all Federal and State regulations and accrediting agency standards.
• ssist in the management of the electronic document management systems including management of the site training records.
• Review batch records and release products.
• ssist with the initiation and risk classification of deviations.
• Inspect and release incoming materials.
• Ensure the electronic copies of SOPs, training materials, validation plans and other regulated documents are maintained.
• ssist in the management of the library of printed documents, manuals and reference materials.
• Work with departments to coordinate, schedule, and prepare for document release and training activities for new or revised procedures, competency assessments, annual GMP training and all other document release and training items as deemed necessary.
• ssist in the creation of SOPs, forms, documents and training materials.
• ssist in the creation, revision, and approval (for minor changes) of SOPs, policies, forms, etc.
• Participate in customer and regulatory audits.
• ssist the QA / RA department with process improvement activities.
• ssist with special projects as assigned.
• Perform all other duties, at the discretion of management, as assigned
• Resolves conflicts with team members and involves functional management as required.

Requirements :