Clinical Quality Assurance Associate/Senior Associate

Location
Durham, NC, United States
Posted
Sep 26, 2020
Ref
1378114
Hotbed
Bio NC
Required Education
Associate Degree
Position Type
Full time
The 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 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 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

Reasonable 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.
  • Provide QA oversight of clinical CROs, Suppliers, and Testing Vendors
  • Perform QA oversight of Clinical Operations, both remotely and on-site through review of documents, eTMF, and site audits
  • Perform qualification audits of clinical suppliers
  • Work closely with external suppliers, clinical operations and internal development teams to ensure project objectives are met in a compliant and timely manner
  • 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 and Clinical Operations 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).
  • Investigate, triage and document quality issues/deviations, and recommend corrective actions/CAPAs related to clinical issues
  • Assist Quality team members to maintain the internal and external audit programs
  • Participate in regulatory and partner audits
  • Assist in training new staff in quality system requirements and applicable regulations
  • Assist QA with other projects and tasks, where applicable (e.g. support of ongoing development and manufacture of Clinical Trial Material)

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 with 5+ years industry experience in Clinical Quality (GCP) with at least 2+ years of Quality Assurance experience; or equivalent education and experience
  • Knowledge of FDA regulations and standards, especially those pertaining to cell therapy, bioanalytical testing and clinical research

Preferred:
  • Quality certification such as ASQ/CQA
  • Additional prior experience in cGMP environment

Travel Requirements
  • This position may require up to 15% domestic 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 mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. 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.