SummaryThe Quality Specialist III is responsible for providing dedicated quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations at Precision BioSciences, including batch release review, deviation assessment, and CDMO oversight. The Quality Specialist III will work closely with QA leadership, operating with supervised independence to execute QA review activities, escalating higher-risk decisions appropriately while building proficiency in risk-based quality decision-making. This position is critical to maintaining regulatory compliance, inspection readiness, and operational continuity as the company's clinical pipeline continues to grow.
Essential Dutiesand ResponsibilitiesReasonable 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.
- Support batch release review and disposition activities for CMC drug substance and drug product, including review of analytical data packages, certificates of analysis, and batch records in accordance with applicable SOPs
- Perform deviation and investigation impact assessments for CMC-related events, documenting findings and supporting root cause analysis in the quality management system under the direction of QA leadership
- Conduct QA review of method validation and technology transfer documentation, assay data packages, and specification verification records for CMC programs in support of PBGENE-HBV and PBGENE-DMD-01
- Participate in CDMO technical and quality meetings, supporting oversight of contract manufacturing and testing organizations in alignment with PBI's quality requirements and supplier qualification program
- Support the implementation and maintenance of CMC QA review checklists and standardized review frameworks to promote consistency, data integrity, and inspection readiness
- Assist with raw data reconciliation and perform QA review of CMC release documentation packages, escalating complex or higher-risk determinations to QA leadership per defined escalation pathways
- Maintain quality records and documentation in ZenQMS and other quality management systems, ensuring completeness, accuracy, and compliance with 21 CFR Parts 210, 211, Part 11, and applicable ICH guidelines
- Support QA SOP training, competency development milestones, and continuous process improvement initiatives within the QA department, contributing to an environment of quality culture and regulatory compliance
QualificationsThe requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
Required:
- Bachelor's degree in Biology, Biochemistry, Chemistry, Microbiology, or a related life sciences discipline and 5+ years of relevant experience in a GMP-regulated environment, including background in quality assurance, research, or biopharmaceutical/gene therapy manufacturing, or equivalent combination of education and experience
- Strong attention to detail in reviewing technical documentation, analytical data, and GMP records
- Demonstrated ability to review and evaluate scientific/technical documentation with attention to detail and a commitment to data integrity
- Familiarity with applicable regulatory requirements including 21 CFR Parts 210, 211, Part 11, and ICH Q10; ability to interpret and apply GMP requirements to day-to-day quality activities
- Strong written and verbal communication skills; ability to clearly document quality findings and prepare concise review memos and summary reports
- Ability to work effectively in a cross-functional team environment, prioritize competing tasks, and operate with increasing independence under QA leadership guidance
Preferred:
- Experience in quality assurance, research, or manufacturing
- Prior experience in a Quality Assurance role within gene therapy, cell therapy, or biologics organization
- Experience with electronic quality management systems (e.g., ZenQMS or equivalent) for deviation, change control, and CAPA management
- Familiarity with ICH Q10, ICH Q2(R2), or related guidance documents applicable to analytical method validation and CMC quality
- Experience with CDMO or CRO oversight in a GMP context, including attendance at technical or quality review meetings
- Background in analytical chemistry, molecular biology, or cell biology with hands-on laboratory experience applicable to CMC assay evaluation and validation
- Basic understanding of GMP manufacturing processes and ability to work with subject matter experts in the context of Quality oversight of manufacturing
- Experience participating in Quality related documentation/investigations (OOS, deviations, change controls, CAPS, etc.)
Travel Requirements - Minimal travel is anticipated for this position. Occasional domestic travel (estimated
Location - This is an office-based position located in Durham, NC.
