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Quality Assurance Specialist III, Temporary

Company: Arcturus Therapeutics Ltd.
Location: San Diego
Posted on: May 16, 2022

Job Description:

WHY WORK FOR ARCTURUS?

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR - lipid-mediated delivery, (ii) STARR--- mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus diverse pipeline of RNA therapeutic and vaccine candidates includes self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Cardiovascular Disease along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics.

Arcturus technologies are covered by its extensive patent portfolio (192 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS, and the Cystic Fibrosis Foundation.

Arcturus Therapeutics is presently recruiting outstanding candidates with experience in the field of mRNA technologies and nanoparticle sciences.

Our corporate culture is dynamic, diverse, and creative. We value collaboration and teamwork. We seek individuals to join us with a genuine passion for the science behind helping to cure disease and improve the lives of patients.

THE OPPORTUNITY

The Quality Assurance Specialist III will utilize knowledge and experience to consistently review GMP relevant documents, document observations, provide feedback to immediate supervisor, and peers to ensure compliance with internal policies and procedures, applicable regulatory guidelines, and phase appropriate CGMPs. The individual will create checklists for review of procedural documents, identify opportunities to improve QA processes for in depth review of executed batch records, protocols and procedures. The QA Specialist III will pay attention to detail to provide assurance that Good Documentation Practices were followed and source data matches with reported data. Knowledge of CGMP regulatory requirements (e.g., 21CFR210-211, 600-610, ICH Q7, Q9 and Q10) is essential. The QA Specialist will assist in streamlining the current process and ensure the review process is able to catch any deviations, non-conformances and other product quality issues earlier. Provide quality metrics to assess project progress and quality level. Record inspection, monitoring activities. Trend Key Performance Indicators (KPIs) and report the data for periodic Quality Management Review Meetings. Monitor quality assurance activities to determine compliance with applicable regulatory requirements.

WHAT YOU WILL CONTRIBUTE


  • Author and revise SOPs, Data Collection Forms and Checklists. Revise SOPs, guidelines, and other technical documents. Identify discrepancies and actions to be taken to prevent deviations and non-conformances due to incorrect documentation. Ensure all procedural documents e.g., SOPs, protocols, work instructions, test methods, method validations, process validations, are reviewed, and approved in a timely manner.
  • Work with cross functional team and suppliers to ensure timely completion of documentation reviews. Ensure compliance with applicable regulatory requirements during review of CGMP and other GxP documents.
  • Assist in the preparation of documentation that will be filed with regulatory authorities (e.g., FDA, Health Canada, EMA, WHO, etc.)
  • Identify deficiencies and discrepancies in procedures and executed documents. Ensure immediate supervisor is notified and actions are taken to correct/address the quality problem(s) in a timely manner.
  • Provide weekly updates to immediate supervisor and QA Team on progress made with reviews and SOPs that are required for the implementation of Quality Program and applicable CGMPs.
  • Review, approve and communicate root cause and corrective action to stakeholders. Provides QA oversight for Quality Events, Deviations/Investigations, CAPAs, Batch Record Reviews, Product Release, Analytical Method Validations, Process Validations, and Change Control initiations, reviews, or approvals.
  • Interact with all departments, work on ways to continuously improve current practices to meet quality plan, corporate goals, and objectives.
  • Drives continuous improvement of core processes to ensure quality is maintained while efficiency is optimized
  • Provide assistance to the QA team on quality procedures, protocols, and documentation.
  • Collect data for Key Performance Indicators (KPIs). Track, trend and report KPIs on a periodic basis for Quality Management Review Meetings.
  • Coordinate investigation of quality issues with customers and suppliers


    WHAT WE SEEK


    • Minimum 8 years of experience in the pharmaceutical, biotech or related industry. Hands-on experience with a paper, electronic or hybrid systems preferred. Strong knowledge of GMPs required. FDA and/ or other regulatory agency experience required. Highly desirable to have a minimum of 5 years of Quality Systems experience.
    • Background in Chemistry, Biotechnology and/or other Life Sciences is required to make decisions using a science-based approach to CGMPs.
    • Strong GMP background is required. Experience with writing technical documents to meet requirements of 21CFR210-211, 21CFR600-610, EudraLex Vol 4.0, ICH Q7, Q8, Q9 & Q10 including application of these regulatory requirements in the day-to-day environment. Experience with authoring legal documents such as Quality Agreements, Business Supply Agreements, legal tenders is a plus.
    • Working experience in the analytical chemistry or biotechnology labs is required for this position.
    • FDA inspections and/or other regulatory agency inspections experience is highly desired.
    • Strong written and verbal communication skills, specifically technical, scientific, communications and oral presentations


      EDUCATION

      BS or MS degree in a science discipline e.g., Life Sciences, Chemistry, Biology, Microbiology.

      WHAT WE OFFER

      An exciting opportunity to join a company that offers a competitive total rewards package that includes:


      • Full range of health benefits including Medical, Dental & Vision with 100% EMPLOYER PAID premiums for employee and family!
      • Employee Stock Purchase Program (ESPP)
      • 401K Match
      • Competitive salaries and bonus plans plus equity via Stock Options
      • Catered lunches
      • Free variety of snacks and beverages
      • Health and Wellness programs
      • $100 Anniversary cash awards with opportunity to increase to $2000!
      • Referral Bonuses
      • On Campus Gym
      • Company sponsored FUN events


        For a deeper dive into our company and corporate culture visit www.ArcturusRx.com

Keywords: Arcturus Therapeutics Ltd., San Diego , Quality Assurance Specialist III, Temporary, Other , San Diego, California

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