Senior Quality Assurance Associate

Location
Durham, NC, United States
Posted
Oct 31, 2020
Ref
1431020
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Precision BioSciences is seeking a Senior Quality Assurance Associate to join the Quality and Compliance Team. The Senior QA Associate will report to the QA Manager and will directly support the GMP manufacturing and testing facility through batch documentation review, deviation management, and supporting compliant processing according to regulatory requirements. He/she will also help to develop and maintain the Quality Management System (QMS) 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 Senior QA Associate will have a hands-on role supporting compliance questions and concerns from multiple teams: manufacturing, QC, validation, warehouse, calibration, and facilities.

Essential Duties and Responsibilities
  • Perform batch documentation review and release to support product disposition
  • Determine if events need to be escalated to deviations. Partner with investigation authors to ensure deviations are robust, complete, and scientifically sound. Review and approve deviations.
  • Assist with Shop Floor QA activities on processing days as required
  • Partner with Operations to build relationships and re-enforce a compliance mindset
  • Perform QA walk-through audits, internal audits, and external audits
  • Review and approve standard operating procedures (SOPs), calibrations, electronic laboratory notebook (ELN) experiments, change controls, validation reports, and environmental monitoring data
  • Work with Quality team members to develop, implement, and maintain a phase appropriate QMS through the creation, review and approval of documentation, including policies and SOPs. Primary focus will be on GMP operations and testing
  • Investigate, triage and document quality issues/deviations and recommend corrective actions/CAPAs related to GMP issues
  • Participate in regulatory and partner audits
  • Participate in equipment/utility/method qualification activities
  • Answer quality-related questions from various teams 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

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

Education/Experience:
  • BS or equivalent in life science or related field and 8+ years industry experience in Quality Assurance for a pharmaceutical, biotech, and/or cell therapy/gene therapy company, or equivalent training and experience
  • Experience approving deviations and/or investigations for GMP processing/testing
  • Knowledge of FDA regulations and standards, especially those pertaining to clinical research and commercial production
  • Experience with GMP manufacturing to support clinical studies
  • Experience in a clean room environment
  • Experience in equipment/utility/method qualification

Preferred Qualifications:
  • Knowledge of cell culture
  • Commercial GMP experience
  • Experience approving major/significant deviations

Location
  • This is an office-based position at our Manufacturing Center for Advanced Therapeutics (MCAT) in RTP, NC

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


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.