Quality Assurance Associate II

Durham, NC, United States
Aug 22, 2020
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Precision BioSciences is seeking a Quality Assurance Associate II to join the Quality and Compliance Team. The QA Associate II 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 II will use a range of QA skills to support manufacturing, QC, warehouse, and facilities at the Manufacturing Center for Advanced Therapeutics.

Essential Duties and Responsibilities
  • 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 review of QC data and characterization testing
  • Investigate, triage and document quality issues/deviations, and recommend corrective actions/CAPAs related to GMP issues
  • Review deviations and change controls
  • Review and approve SOPs and environmental monitoring data
  • Review and approve calibration records and completed preventive maintenance work, ensuring compliance to Quality Systems
  • Perform QA functions for the drug product inventory life cycle
  • When needed, 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 data audits, QA walk-through audits, internal audits, and external audits
  • Perform incoming goods disposition (review incoming goods, perform appropriate disposition, and apply status labels)
  • 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.
  • Participate in regulatory and partner audits
  • Answer quality-related questions 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

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

  • 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 or gene therapy company; or equivalent education and experience
  • Knowledge of FDA regulations and standards
  • Commercial or clinical GMP experience
  • Experience reviewing deviations, CAPAs, and change controls
  • Knowledge of cell culture and/or aseptic techniques

Preferred Qualifications:
  • Experience in a clean room environment
  • Experience in equipment/utility qualification
  • Knowledge of Environmental Monitoring programs
  • Experience writing deviations and/or change controls

Travel Requirements
  • This position may require up to 5% local travel

  • This is an office-based position at our Manufacturing Center for Advanced Therapies (MCAT) in the Research Triangle Park area in Durham, NC

Precision BioSciences, Inc. is dedicated to improving life by developing advanced tools to edit DNA with a uniquely specific approach. Our proprietary method relies on a single small enzyme, ARCUS Nuclease, which combines cutting with sequence recognition and can be redesigned to find and edit new target sites across the genome. This simple, powerful gene editing solution allows us to create products that solve not just treat, but solve significant problems in oncology, genetic disease, agriculture, and beyond. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented, committed people who are excited to be a part of the medical and scientific breakthroughs enabled by Precisions next generation gene editing technology. For additional information, please visit www.precisionbiosciences.com

Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.