Job: Shop Floor QA Associate, Precision BioSciences, Durham, NC
Precision BioSciences is seeking a Quality Assurance Associate to join the Quality and Compliance Team. The QA Associate will report to the QA Manager and will directly support the GMP manufacturing and testing facility. She/he will also help to develop and maintain the Quality Management System through the development, implementation and maintenance of quality standards, policies and procedures. This person will work within the Quality team to ensure compliance with FDA and other regulatory agency requirements, as well as customer and internal company quality systems requirements. The QA Associate will be working predominantly in a clean room environment and will have an active role answering compliance-related questions and supporting manufacturing on the floor.
Essential Duties and Responsibilities
(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.)
Actively perform manufacturing QA activities in a clean room environment to include continuous observation, review of documentation, and assurance of proper aseptic technique practices.
Perform initial QA batch record review (evaluating Good Documentation Practices, checking calculations, ensuring disposition of materials in the genealogy, and confirming proper transcription of data)
Perform QA walk-through audits, internal audits, and external audits as needed
Perform incoming goods disposition (Review incoming goods, perform appropriate disposition, and apply status labels)
Review and approve SOPs and environmental monitoring data
Work with Quality team members to develop, implement, and maintain a phase appropriate Quality Management System (QMS) through the creation, review and approval of documentation including policies and standard operating procedures (SOPs). Primary focus will be on cGMP compliance for Internal QA.
Investigate, triage and document quality issues/deviations, and recommend corrective actions/CAPAs related to GMP issues
Participate in regulatory and partner audits
Answer quality-related questions on the floor and escalate any concerns to the Quality Manager
Assist in training new staff in quality system requirements and applicable regulations
Assist QA with other projects and tasks, where applicable
This is an office-based position at our Manufacturing Center for Advanced Therapies (MCAT) in the Research Triangle Park area in Durham, NC
BS or equivalent in life science or related field and 5+ years industry experience in Quality Assurance for a pharma, biotech, and/ or cell therapy gene therapy company, or equivalent combination of education and experience
Knowledge of FDA regulations and standards
Commercial GMP experience
Experience in a clean room environment
Knowledge of cell culture
Experience in equipment/utility qualification
Knowledge of Environmental Monitoring programs