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Document Control Specialist - Quality Assurance

Company: Catalent
Location: Chelsea
Posted on: January 13, 2022

Job Description:

Job TitleDocument Control Specialist - Quality AssuranceJob Summary The Document Control Specialist is responsible for performing various administrative tasks in support of the Quality Assurance department and its clients including but not limited to SOP review, supporting the QA Archive, Electronic Document Management System (EDMS), and GxP Training Program. The Document Control Specialist participates in independent and team projects as defined by the department manager. The Role

  • Facilitates the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications, etc.) by functioning as a document workflow coordinator.
  • Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving.
  • Provides day-to-day support of the electronic document management system (EDMS), and operational controls to maintain the validated state (compliance with 21 CFR Part 11)
  • Collaborates with team to identify opportunities for process improvement in the Document Control program and works cross functionally to implement, as appropriate.
  • May assist with end-user training for new users of the EDMS and document control business processes.
  • Participates in Standard Operating Procedures generation and review.
  • Provides day-to-day operation support for client groups (e.g., scheduling, reporting, records archiving)
  • Other duties as assigned. The Candidate
    • Associates Degree Required. Bachelor's degree preferred.
    • Minimum of 0-3 years of relevant work experience in the regulated Biotechnology or Pharmaceutical industries or relevant comparable background highly preferred.
    • Experience with Electronic Document Management and Learning Management Systems preferred (EDMS: Documentum, LMS: ComplianeWire)
    • Familiar with applicable regulatory requirements (e.g., 21 CFR Parts 11, 210, 211, 820).
    • Must be proficient in MS Office Suite. Excellent oral and written communication skills.
    • Requires physical activity such as standing for long periods of time, walking, bending, and working with hands. Catalent's standard leadership competencies that are used to interview and for Performance & Development:
      • Leads with Integrity and Respect
      • Delivers Results
      • Demonstrates Business Acumen
      • Fosters Collaboration and Teamwork
      • Champions Change
      • Engages and Inspires
      • Coaches and DevelopsWhy join CatalentFast-paced, dynamic environmentHigh visibility to members at all levels of the organization152 hours of PTOCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Keywords: Catalent, Chelsea , Document Control Specialist - Quality Assurance, Other , Chelsea, Massachusetts

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