Research Quality Assurance Associate

Location
Durham, NC, United States
Posted
Apr 18, 2021
Ref
1550696
Hotbed
Bio NC
Required Education
Other
Position Type
Full time
Precision BioSciences seeks to hire a Research Quality Assurance Associate to join our growing Quality and Compliance Team. This person will report to the QA Manager and will help to develop and maintain the compliance framework for research and development (R&D) activities through the development, implementation and maintenance of quality standards, policies and procedures. This role will be a crucial part of ensuring compliance with FDA and other regulatory agency requirements, as well as supplier and internal company quality systems requirements.

Essential Duties and Responsibilities
  • Perform QA oversight of R&D work though:
    • Review and approval of completed experiments in the Electronic Lab Notebook (ELN) system
    • Review and approval of procedures related to R&D operations
    • Plan, conduct and follow-up on routine audits of R&D operations
    • Work with R&D and Training staff to determine compliance related education required
  • Serve as Quality representative on project teams related to research programs
  • Support internal audit program across all phases of development
  • Interface with partner Quality Unit for partnered research programs
  • Review of internal characterization data/reports/certificates of analysis in support of lot release
  • Review of pre-GMP production and testing records for material used to support regulatory filings
  • Perform Quality Control review of regulatory filings related to R&D data
  • Support External Quality (GMP, GLP, GCP) as available
  • Participate in and approve quality investigations, assessments, and reviews or evaluations of quality events such as deviations, CAPA, change records, etc. and recommend corrective actions/CAPAs related to cGMP and GCP issues
  • 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)
  • Participate in regulatory and partner audits

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 5+ years industry experience in Quality Assurance and/or R&D; or equivalent combination of education and experience
  • Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, bioanalytical testing, and clinical research
  • Ability to work independently and collaborate successfully across multiple cross-functional scientific and research teams
  • Excellent communication and problem-solving skills

Travel Requirements
  • This position may require up to 10% domestic out-of-state travel in the future, when company travel resumes

Location
  • This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.


Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. This isnt just a statement supporting the products that were developing its a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com

Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide 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.