Senior Quality Assurance Associate - Vendor Management

Location
Durham, NC, United States
Posted
Nov 04, 2020
Ref
1434317
Hotbed
Bio NC
Required Education
Associate Degree
Position Type
Full time
The Senior Quality Assurance Associate, within the Quality and Compliance Team, will report to the External Quality Manager, and receive supervision from the senior members of the team. The Senior QA Associate will 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 External Quality team to ensure 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 external cGMP manufacturing and testing suppliers
  • Perform QA oversight of clinical operations, both remotely and on-site
  • Perform qualification audits of GMP, GLP and GCP suppliers
  • Work closely with external suppliers, clinical operations and internal development teams to ensure project objectives are met in a compliant and timely manner
  • Review of internal characterization data/reports/CoAs in support of lot release.
  • Partner with Technical Operations, Process Development and Bioanalytical Development teams to review CMC documents such as batch records, methods, validation protocols and reports, and testing data
  • 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
  • Support submission of regulatory documents (e.g. IND/DSUR)
  • Track Quality documents and records (e.g. deviations, CAPAs, documents, audits, approved vendors) to ensure compliance with internal and external requirements
  • 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 and GCP operations
  • Work with Quality team members to maintain the internal and external audit programs
  • Participate in regulatory and partner audits
  • Support other QA functions 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 2+ years industry experience in manufacturing/testing (GMP) and/or clinical (GCP) Quality Assurance; or equivalent combination of education and experience
  • Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, bioanalytical testing, and clinical research
  • Excellent communication and problem-solving skills
  • CRO or CDMO experience preferred

Travel Requirements
  • This position may require up to 25% 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 is dedicated to improving life. Our mission is to cure genetic disease, overcome cancer, and feed the planet. We are achieving this with ARCUS, the first therapeutic-grade, naturally-derived genome editing system that uniquely combines the specificity and efficacy required to overcome lifes greatest genetic challenges . Learn more about the pioneers leading the next genetic revolution at: 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.