Document Control Manager jobs in Massachusetts

Document Control Manager oversees document and record control operations, policies, and procedures for the secure management and access of company information assets. Establishes security protocols for the access, storage, backup, maintenance, reproduction, protection, and disposition of all documents. Being a Document Control Manager evaluates media formats and recommends storage requirements to protect and secure records/information. Develops and manages access and control procedures to comply with requirements for varying levels of security classifications specified by the governing authority. Additionally, Document Control Manager maintains auditing, monitoring, and change control systems to ensure document integrity, quality, and version control. Typically requires a bachelor's degree. May require security clearance. Typically reports to a director. The Document Control Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Document Control Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Manager, Quality Assurance Document Control
  • ASTELLAS
  • Westborough, MA FULL_TIME
  • Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

     

    Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

     

    This position is based at our Westborough, MA site. This is an onsite position.

     

    Purpose and Scope:

     

    The Manager, Quality Assurance Document Control (QADC) role oversees the daily operations of the GMP QA Document Control team. This position directly supports ongoing manufacture of biological preclinical and clinical trial materials by providing timely and compliant document issuance, reconciliation, and document implementation support.

     

    Essential Job Responsibilities:

    • Manages and grows the QA Document Control team responsible for administration of the cGMP Documentation program. This includes document issuance / reconciliation; SOP implementation, periodic review, and obsoletion; organization and management of critical cGMP documentation in the QA file room; and oversight of Astellas's records and information management program at the AIRM location. Provides real-time document consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.
    • Collaborates closely with GMP department managers at the AIRM location to determine document needs, establish, and improve necessary document templates, and guide QADC staff to support project needs and maintain site compliance with good documentation practices and cGMP data integrity requirements.
    • Partners with functional areas to conduct periodic review of existing cGMP procedures.
    • Oversees the QA Document Control and GMP records and information management functions. Ensures adequate systems are in place to achieve and maintain records retention compliance pursuant to Astellas policies and regulatory requirements.
    • Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.

    Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.

     

    Quantitative Dimensions:

    This position will regularly operate in a time-sensitive environment, with direct impact on the ability to sustain key manufacturing activities and provide value to patients in need.

     

    Organizational Context:

    Reports to the Senior Manager of Quality Assurance Operations. Directly manages training specialists and collaborates closely with both cross-functional and QA peers.

  • 10 Days Ago

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Sr. Manager/Associate Director of Document Control
  • Viridian Therapeutics, Inc
  • Waltham, MA FULL_TIME
  • Description At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to...
  • 1 Month Ago

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Senior Manager/Associate Director, Quality Assurance, Systems, Training and Document Control
  • xenon
  • Boston, MA FULL_TIME
  • Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the liv...
  • 15 Days Ago

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QA Document Control Specialist
  • Orion
  • Worcester, MA FULL_TIME
  • Job description Orion Group and our largest US client have an exciting contract opportunity for an experienced QA Document Control Specialist in Worcester,MA!! We are seeking individuals who can assis...
  • 21 Days Ago

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Document Control Specialist I
  • Werfen
  • Bedford, MA FULL_TIME
  • Overview Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solut...
  • 23 Days Ago

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Document control specialist
  • Jobot
  • Norton, MA FULL_TIME
  • Construction Document Control Specialist (Potential Hybrid Role) This Jobot Job is hosted by : David Rocha Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. ...
  • 24 Days Ago

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Document Controls Lead
  • Cornerstone Transportation Consulting
  • Anaheim, CA
  • Job Description Job Description Cornerstone Transportation Consultants is seeking an experienced Project Administrative ...
  • 3/29/2024 12:00:00 AM

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MANUFACTURING FACILITY QUALITY ELECTRICAL TESTING LEAD POSITION
  • Sora Power Inc
  • Corona, CA
  • Job Description Job Description Responsibility and Authority: Performs a variety of duties including, but not limited to...
  • 3/29/2024 12:00:00 AM

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Document Controls Manager
  • CSA Group
  • San Juan, PR
  • Job Description Job Description Join Our Growing Team CSA provides the ideal place for you to develop or start your care...
  • 3/28/2024 12:00:00 AM

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Document Control Lead
  • Amentum
  • Englewood, CO
  • Amentum is currently searching for a Document Control Lead to work in our Englewood, CO office. **Minimum Requirements**...
  • 3/28/2024 12:00:00 AM

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Document Control Lead - ARB
  • PRIMORIS USA
  • Lake Forest, CA
  • Document Control Lead As a Document Control Lead, your primary responsibility will be to manage and organize project-rel...
  • 3/28/2024 12:00:00 AM

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Document Control Manager
  • Matrix NAC
  • Moreno Valley, CA
  • Job Summary The Document Control Manager ensures that document control processes comply with internal procedures and reg...
  • 3/26/2024 12:00:00 AM

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Administrator - Engineering and Human Resources
  • Amsted Industries
  • Greenville, SC
  • Main responsibilities (Other duties may be assigned, per business needs): Safety: exhibit safe work habits when working ...
  • 3/26/2024 12:00:00 AM

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Assistant Project Manager
  • Murrieta Development Company
  • Temecula, CA
  • Job Description Job Description Assistant Project Manager Summary Local Construction Company is looking for an Assistant...
  • 3/25/2024 12:00:00 AM

Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River. Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Document Control Manager jobs
$129,012 to $200,468

Document Control Manager in Kennewick, WA
The Document Control Manager will be the architect of best practice procedures and processes that are required to support document control activities.
February 16, 2020
Document Control Manager in High Point, NC
Document Control Managers make sure that the documents of an organization are properly stored and easily accessible.
November 30, 2019
Document Control Manager in Buffalo, NY
Coordinates project start and closure with the Intel construction information management manager.
December 01, 2019
The Document Controller is in charge of the daily management of documents on a Project or in a Department.
February 15, 2020