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Quality Assurance Coordinator

Employer
Precision BioSciences, Inc.
Location
Durham, NC, United States
Start date
Jul 20, 2019

View more

Discipline
Clinical, Clinical Project Management, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC

Job Details

The Quality Assurance Coordinator within the Quality and Compliance Team, will report to the QA Manager. The QA Coordinator will primarily support quality management systems, including document control and record issuance, deviation management, auditing, training, and administration of electronic lab notebooks. 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, from pre-IND through commercialization.

Essential Duties and Responsibilities
  • Act as the primary contact for formatting documents prior to loading into the electronic Quality Management System (eQMS), advising co-workers of the proper template to use, and assisting with completion of document attributes prior to workflow initiation; maintain internal tracking system for document control, including assigning unique identification numbers; become a Subject Matter Expert in the eQMS, including initiation and management of workflows
  • Maintain paper and electronic files of GxP documents and records at PBI
  • Assist Quality team members with Document Control processes, including issuance of serialized records, at manufacturing / QC facility
  • Review and QA approval of standard operating procedures (SOPs)
  • Work with Quality team members to help develop, implement, and maintain a phase- appropriate Quality Management System (QMS) through standard operating procedures (SOPs) review, as well as, establishing effective and user-friendly system execution practices
  • Work with Quality team members to maintain paper documents off-site at third party storage facilities
  • Assist in performance of Quality internal and external audits.
  • Drive compliant completion of SOP training across the company and escalate negative trends
  • Participate in partner audits and regulatory inspections
  • Escalate potential concerns and areas for improvement
  • Train new staff of all levels in quality system requirements, eQMS, electronic laboratory management, and other applicable regulations
  • Optimize the training matrix
  • 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

Language Ability
  • Ability to read, analyze, and interpret common scientific and technical journals, experiments, and reports
  • Ability to respond to common inquiries from internal customers and escalate questions/ concerns from regulatory agencies or members of the business community

Computer Skills
  • To perform this job successfully, an individual should have knowledge of Microsoft Office software suite

Soft Skills
  • Attention to detail
  • Strong organizational skills
  • Ability to handle multiple tasks and projects
  • Interact in a collaborative manner with staff at all levels

Physical Demands

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 or feet; talk and hear.
  • The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl.

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.

Company

Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com

Stock Symbol: DTIL

Stock Exchange: NASDAQ

Company info
Website
Phone
919-314-5512
Location
302 East Pettigrew Street
Durham
North Carolina
27701
US

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