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Document Control Specialist

DivIHN Integration Inc
Kennebunk, ME Full Time
POSTED ON 2/3/2025
AVAILABLE BEFORE 4/30/2025

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at

https : / / divihn.com / find-a-job /

to learn more and view our open positions.

Please apply or call one of us to learn more

For further information please contact our Talent Specialist :

Nagarajan |

630-847-0953

Title : Document Control Specialist

Location : Kennebunk, ME

Duration : 9 Months

Description : Schedule :

M-F, 8am 4 : 30pm, Onsite 100%

  • Responsible for administration of quality management system documents and records required for Client Life Sciences processes. Responsible for initiation of document changes, distributions, notifications and fulfilling internal and external document distribution.

Must haves :

  • Proficiency in Microsoft Office and Excel
  • Ability to follow written procedures
  • Detail oriented
  • Ability to work autonomously
  • Description of Work :

  • Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
  • Initiates Change Controls and Document Change Requests to update procedures and processes.
  • Works within departments and with various departments to update processes and procedures.
  • Assists in managing the document review and retention processes.
  • Supports or leads continuous improvement initiatives for document control related processes.
  • Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)
  • Other duties as required
  • Minimum Qualifications :

  • 2 years related experience required. Associate or bachelor's degree in life sciences, engineering, or a related field preferred. Prior experience in a manufacturing environment is preferred.
  • Skills / Experience :

  • Previous experience using ETQ or other Document Management software preferred
  • Proficiency in Microsoft office
  • Experience in ISO 9001 or other Quality System standards
  • ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
  • Must be detail oriented and accurate in execution of work
  • Able to work well both independently and in a group setting
  • About us :

    DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

    DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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