GMP Quality Assurance Specialist

Job Title: Quality Assurance Specialist Job Description The Quality Assurance Specialist provides critical support to Quality Operations with a primary focus on material and batch release activities in a fast-paced pharmaceutical and cell therapy environment. Working within established GMP processes and under moderate supervision, this role helps maintain compliance with Good Manufacturing Practices (GMP) and current Good Practices (cGxP) regulations. The specialist applies developing professional knowledge, strong attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities that contribute to the manufacture of an innovative cell therapy for chronic kidney disease. Responsibilities Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases in accordance with established procedures. Prepare and conduct initial reviews of batch and material release documentation to ensure conformance with applicable SOPs, specifications, and acceptance criteria. Evaluate completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and internal requirements, and escalate discrepancies to QA staff. Report key quality metrics and performance indicators using established templates and reporting tools. Perform hands-on monitoring of production and non-production activities, identifying and promptly reporting observed non-compliance to Quality Management. Support confirmation that finished products conform to internal standards and applicable cGxP regulations. Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management. Assist in the investigation of deviations under the guidance of QA staff, contributing to root cause identification and proposing corrective actions for review and approval. Identify compliance risks and clearly communicate observations to management, supporting implementation of assigned action plans to mitigate risks. Promptly escalate critical quality issues to management with relevant documentation and context. Regularly review and update GMP system procedures, as assigned, to ensure alignment with current regulatory standards and company policies. Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management. Assist in the implementation and maintenance of regulated Quality Systems under the direction of QA personnel. Support audit preparation activities and contribute to continuous improvement of manufacturing quality and quality assurance processes. Essential Skills Associate’s Degree and years of relevant experience in a GMP-regulated environment, or a Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, or a related field with 2 years of relevant experience in a GMP-regulated environment. Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations. Experience with batch record review and material release documentation. Familiarity with deviation management and CAPA processes, with experience participating in or supporting investigations preferred. Basic familiarity with FDA, EU, and/or ISO regulatory frameworks preferred. Hands-on experience in Quality Assurance within pharmaceutical, biotech, or manufacturing quality environments. Ability to perform inspection, document control, and audit support activities in compliance with established procedures. Strong attention to detail and accuracy in documentation, data entry, and record review. Effective written and verbal communication skills to clearly document findings and communicate quality issues. Ability to identify compliance risks and escalate issues appropriately within Quality and management. Additional Skills & Qualifications Experience working in GMP-regulated pharmaceutical or cell or gene therapy manufacturing environments. Exposure to cell therapy or advanced therapy medicinal products and an interest in innovative therapies for chronic kidney disease. Experience supporting audit preparation and participating in internal or external audits. Demonstrated ability to support investigation and analysis activities related to deviations and CAPA. Comfort working in a fast-paced environment with evolving quality system requirements. Strong organizational skills and the ability to manage multiple quality tasks and priorities. Ability to collaborate effectively with cross-functional manufacturing and qual