The Quality Assurance Associate, within the Quality and Compliance Team, will report to either the Sr. Director of Quality and Compliance or other senior staff, 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 customer and internal company quality systems requirements.
Essential Duties and Responsibilities
Perform critical in-phase audits of GLP operations, both internally and externally
Perform QA oversight of clinical operations, both remotely and on-site
Perform qualification audits of GLP and GCP suppliers
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 GLP and GCP operations, with some GMP oversight included
Investigate, triage and document quality issues/deviations, and recommend corrective actions/CAPAs related to GLP and GCP issues
Work with and assist Quality team members to maintain the internal and external audit programs
Participate in regulator and partner audits
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 with at least 2 - 10 years industry experience in pre-clinical (GLP) and/or clinical (GCP) Quality Assurance; experience with Good Manufacturing Practices (GMP) a plus
Knowledge of FDA regulations and standards, especially those pertaining to pre-clinical and clinical research
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
To perform this job successfully, an individual should have knowledge of Microsoft Office software suite.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The employee must occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, color vision, peripheral vision and ability to adjust focus.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel and talk or hear.
The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
This position requires up to 15% travel.
Precision BioSciences’ mission and vision is to translate the world’s 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. Precision’s 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.