Quality Assurance Associate

Overview

Quality Assurance Associate at Katalyst CRO. 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 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.

• Perform job functions in compliance with internal Standard Operating Procedures, Current Good Manufacturing and Tissue 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.

• Discretion in handling confidential and sensitive matters.
• GMP manufacturing experience.
• Strong leadership skills with demonstrated ability to collaborate effectively across teams and functions.
• Strong verbal and written communication skills.
• Strategic thinking and excellent analytical skills.
• Excellent organizational, time management, and problem-solving skills.
• Ability to work well under deadlines and pressure.
• Knowledge and proficiency in navigating the electronic document control system.
• 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.
• Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
• Ability to quickly learn new software programs as needed.