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Document Control Specialist

Company: Kelly Services
Location: Bonsall
Posted on: April 9, 2021

Job Description:

Kelly Services-- has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Document Control Specialist at a prestigious Fortune 500-- company working in Carlsbad.----Important information:--This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the "Submit Resume" button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position () however your resume must be received via the "Submit Resume" button included within.--Job Title: Document Control Specialist--Pay Rate: $29.25 per hour-- ----The role is responsible for Document Control Management of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG).BID is experiencing an outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.--How will you make an impact?We are looking for a self-driven, experienced and resourceful Document Control Specialist to support with the buildout of our document control system, ensuring compliance to all applicable standards.--What will you do?--------------------------

  • Day-to-day support of the document control workflow, which is the vehicle to execute the request for changes within an ISO 9001 and Pharmaceutical GMP Quality Management System.
  • Support the coordination, preparation and implementation of controlled documents via Document Change Orders (DCOs) and Engineering Change Requests (ECRs).
  • Review and edit product documentation for consistency in content. Interact with appropriate departments/sites to resolves discrepancies.
  • Assist with global document review boards ensuring that document changes which impact multiple sites are appropriately updated congruently to prevent process drift.
  • Drive continuous improvement of Document Control process by employing Practical Process Improvement concepts, managing metrics, reporting and communicating internally to Leaders and diverse audiences.
  • Determine required approvers and route corresponding DCO/ECR in Agile. On completion of change, ensure manufacturing documentation is available at the point of use. Provide notification to appropriate departments, where applicable.
  • Prepare physical binder of Quality Management System (QMS) documents for audit support.
  • Train staff to document control processes, Good Documentation Practices (GDP), etc.
  • Compile master data for entry into Agile document management system
  • Transfer documents to new approved templates
  • Perform other duties and cross training, as assigned--Education
    • Associate degree from accredited college/university or equivalent experience. Bachelor's degree in Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering preferred.--Experience
      • Requires a minimum of 2-3 years relevant experience in a regulated document control environment.
      • Strong working knowledge of computer applications and current software (Microsoft Excel, Outlook, Word, Project and PLM/ERP system).--Knowledge, Skills, Abilities
        • Experience with Agile and MasterControl electronic document control systems preferred.
        • Works independently on new and on-going assignments.
        • Identifies and solves problems using established business rules and procedures.
          • Detail oriented and accurate.
          • Strong verbal and written communication skills.
          • Continuous improvement minded.
          • Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001, ISO 13485, MDSAP, excipient manufacturing regulations) and 21 CFR part 210/211, ICH Q7 and Eudralex volume 4 experience preferred.----We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: .Kelly Services-- is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.Kelly Services is an Equal Opportunity Employer----Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, San Diego , Document Control Specialist, Other , Bonsall, California

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