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System One QA Associate Specialist – Document Control in Seattle, Washington

Job Title: Quality Assurance Document Control (QADC) Associate Specialist

Location: Seattle, WA

Type: Contract

Overview

Leading Pharmaceutical company looking for an experienced QA Document Control Specialist. Ideal candidates should have 2+ years of Document Control and report experience with at least 1 year being in cGMP/FDA regulated environment.

Responsibilities

  • Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.

  • May write and revise document control procedures including participating in the development and roll-out of document control tools.

  • Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.

  • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.

  • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.

  • Generate document management system reports for Quality Council metric reporting.

  • Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.

  • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.

  • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

    Requirements

  • Education: Bachelor’s degree or equivalent

  • Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.

  • Strong communication and customer service skills.

  • Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.

  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.

  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively.

  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.

  • Possess project management skills.

  • Experience interacting with FDA or other regulatory agencies strongly preferred.

  • Strong knowledge of cGMPs and domestic regulatory requirements.

  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).

  • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.

    Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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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