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System One RA/QA Operations Specialist (PERM) in Princeton, New Jersey

Position Title: RA/QA Operations Specialist

Location: Princeton, NJ

Schedule: Hybrid

Salary: $50,000- 55,000/ yearly

Type: Direct Hire

Overview

Joule has an opening for a Direct Hire RA/QA Specialist to work full-time on a hybrid schedule in Princeton, NJ. Some of the main responsibilities include conducting regulatory documents or submissions, filing or processing, cleaning and manage folders or files, and SOP Committee activities. You must be able to work onsite 1-2 assigned day a week, no exceptions, as this is a hybrid position.

Responsibilities

  • QA document filing or processing

  • Conducting RA/QA department administrative functions, including expense submission preparation, file department training documents.

  • Format and/or word-process regulatory submission documents to meet eCTD standards.

  • Maintain files of department correspondence, contracts/service agreements, consultant information, expense vouchers, payment requests, shipping receipts and other miscellaneous administrative information.

  • Make travel arrangements, submit and track expense reports, maintain and order office supplies for all RA department members.

    Requirements

  • Associate degree preferred

  • Minimum 2 years of administrative/general office experience with knowledge or experience in regulatory operations or RA/QA administrative work a plus.

  • Pharmaceutical or biotechnology company background or experience preferred.

  • Technical skills such as: proficiency in MS office, Adobe Acrobat, EDMS, ISIToolBox, ISIWriter, etc.

  • Knowledge of preparation of regulated documents or pharmaceutical industry a plus.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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