Quality Assurance Associate

Quality Assurance Associate

The Quality Assurance Associate assists in the management, administration, and maintenance of the Quality System to ensure compliance with internal standards and external regulatory requirements. This role is responsible for verifying that products are manufactured in accordance with applicable procedures and specifications in a cGMP-compliant manner. The associate partners closely with manufacturing and operations throughout the production life cycle to ensure procedures are followed, activities are appropriately documented, and products are released in alignment with quality and regulatory expectations.

• Communicate and partner on a continuous, daily basis with production management to understand and support activities on the production floor.
• Issue batch records and ensure they are complete, accurate, and available to support production activities.
• Routinely review production floor activities and documentation to verify compliance with established procedures and quality requirements.
• Stay current with applicable standard operating procedures (SOPs) related to shop floor practices, including cleaning, room conditions, changeovers, and line clearance, and verify ongoing compliance with these SOPs.
• Support production management in developing and conducting training related to quality procedures, documentation practices, and shop floor compliance.
• Manage quality events associated with production activities by using risk-based principles to assess events, determine appropriate actions, and ensure timely and thorough resolution.
• Manage deviations by coordinating, documenting, and supporting investigations as required, ensuring that root causes and corrective actions are clearly defined.
• Review completed batch records and perform product release activities as authorized by the Quality Assurance leadership, ensuring all quality and regulatory requirements are met prior to release.
• Ensure proper filing, storage, and control of quality documentation to maintain data integrity, traceability, and audit readiness.
• Sample raw materials and packaging components as needed to help the department meet quality and production timelines.
• Author and edit SOPs in collaboration with Quality Assurance leadership to ensure procedures are clear, current, and aligned with regulatory expectations.
• Support Quality Assurance leadership in conducting departmental training and facilitating workflow within the quality function to improve efficiency and consistency.
• Work closely with Quality Assurance leadership to streamline existing processes and develop new processes and procedures that enhance business performance and quality outcomes.
• Support the preparation and regular presentation of quality assurance program elements, including metrics and trends, to site leadership through formal Management Review.

• Minimum 3 years of experience in quality assurance within a drug and/or cGMP-regulated environment.
• Demonstrated experience with cGMP requirements and their application in a manufacturing setting.
• Hands-on experience with batch record issuance, review, and product release activities.
• Experience managing quality events and deviations, including coordinating and documenting investigations.
• Knowledge of quality assurance and quality control principles, including document control, audits, CAPA, and inspection readiness.
• Strong sense of ownership and accountability for quality outcomes and compliance.
• Proven ability to build partnerships and collaborate effectively with production and other departments.
• Strong attention to detail with the ability to identify and correct documentation and process issues.
• Excellent oral and written communication skills to interact with cross-functional teams and document quality activities clearly.
• General knowledge and exposure to manufacturing equipment and processes in a regulated environment.
• Ability to work with minimal supervision while prioritizing and managing multiple projects and tasks.
• Flexibility and a strong work ethic, with the ability to respond quickly to changing business and production needs.
• A proactive, "do whatever is necessary" attitude…