QA Specialist

QA Specialist (Contract / Consultant)

The QA Specialist (Contract / Consultant) plays a key role in ensuring product quality by managing core quality systems, overseeing batch disposition, and supporting compliance in a fast-paced cell therapy manufacturing environment in Sacramento, CA. This position focuses on deviations, change control, CAPA, and document management, while making timely batch release decisions to support rapid processing timelines and high-quality standards.

• Oversee the management of quality systems, including deviations, change controls, corrective and preventive actions (CAPAs), and document control.
• Ensure that all deviations are investigated thoroughly and in a timely manner, including root cause analysis and implementation of effective corrective actions.
• Review and approve change controls to ensure compliance with regulatory requirements and internal procedures.
• Maintain and continuously improve CAPA processes to ensure effective resolution of quality issues.
• Evaluate batch records and associated documentation to make informed batch release decisions.
• Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards prior to release.
• Monitor and document quality issues related to batch production and implement corrective measures as needed.
• Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.
• Conduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.
• Stay informed about current regulations, industry trends, and best practices in pharmaceutical and cell therapy quality assurance.
• Assist in preparing for internal and external audits, ensuring all quality systems and documentation are audit-ready.
• Provide training and guidance to staff on quality systems, processes, and compliance requirements.
• Serve as a point of contact for quality-related inquiries and issues, fostering a strong culture of quality across the organization.
• Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
• Identify areas for improvement within quality operations and propose appropriate solutions.
• Track completion of quality records and maintain relevant quality metrics.
• Support deviation review, product release, batch record review, and batch closure activities.
• Work collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.
• Communicate effectively with team members and contribute to a positive and collaborative work environment.
• Actively participate in group and project teamwork, including project and process improvement initiatives.
• Adhere to current Good Manufacturing Practice (cGMP) policies and procedures, including accurate and timely documentation activities.
• Provide on-call support outside regular business hours as needed.
• Perform other duties as requested by leadership to support Quality operations.

• Bachelor's degree in a relevant scientific discipline (such as biology, biochemistry, immunology, or a related field) with at least 3 years of experience in quality control testing, analytical development, or GMP; or a Master's degree in a relevant scientific discipline with at least 1 year of experience.
• Demonstrated understanding of FDA regulations, GMP compliance, and quality system processes.
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment (preferred).
• Prior experience performing internal audits and managing document control systems.
• Proven ability to manage deviations, including critical deviations, and support product batch release activities.
• Ability to meet project and testing timelines in a fast-paced and regulated environment.
• Strong organizational skills with the ability to manage multiple tasks concurrently.
• Detail-oriented mindset with a strong commitment to data integrity and accuracy, including the ability to identify and resolve data management issues.
• Ability to work both independently and collaboratively within a multi-disciplinary team.
• Effective written and verbal communication skills to support collaboration and training.
• Ability to respond constructively to changing priorities and operational challenges.
• Capability to adhere to cGMP policies and procedures and maintain high-quality documentation.
• Capacity to wear appropriate personal protective equipment and meet cleanroom gowning requirements, as applicable to the role.
• Willingness to work overtime and provide on-call support as required by business needs.

• Experience as a QA representative or QA specialist supporting deviation review, product release, batch record review, and batch closure.
• Comfort working with minimal training and quickly integrating into established…