Role: Quality Assurance Associate

Location: Northbridge, CA

Duration: 6 Months Contract

Essential 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.

• Assist in the management of the electronic document management systems including management of the site training records.

• Review batch records and release products.

• Assist 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.

• Assist 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.

• Assist in the creation of SOPs, forms, documents and training materials.

• Assist in the creation, revision, and approval (for minor changes) of SOPs, policies, forms, etc.

• Participate in customer and regulatory audits.

• Assist the QA/RA department with process improvement activities.

• Assist 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.

Education, Experience, and Licensure - Bachelor’s Degree in Biology or related field.

• 2+ years’ experience in Quality Assurance role in a regulated environment; cGMP and cGLP Clean Room experience preferred.

Salary info:

$25 - $30 / hr