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Document and Business Administrator I

Company: Iconma, L.L.C.
Location: Palo Alto
Posted on: May 3, 2021

Job Description:

Document and Business Administrator I

Location: Palo Alto, CA

Duration: 9 months

Description:

The role: Document and Business Administrator - Palo Alto

Position Overview:

* Client's Health PA includes products and facilities across the globe. As such, having a single, comprehensive document control system is essential to efficient operations and overall regulatory compliance. As a document administrator at client Health, you will support the entire global organization using client Health electronic tools to appropriately manage all forms of documentation. * Your role is the gatekeeper for document work-flow processes including document approval, release, changes, and records management. You will also provide business administration support for the existing and developing QMS tools for the users.

Additional Role Description:

* As a Document and Business Administrator within client's Health PA, you will be a part of the QRS (Quality, Regulatory and Safety) organization and specifically report into the QRS Operations team. Your role provides support to all groups within client Health to ensure that documentation is reviewed, approved, released and managed appropriately including compliance with a variety of regulatory requirements. The Document Administrator performs tasks such as reviewing documents and change requests to be routed for review and approval, ensuring the appropriate approvers, managing the effectiveness and efficiency of the process, and providing metrics to Management Review for process monitoring.

In addition, this role will ensure the successful use and adoption of the QMS systems including LMS and DMS. This will be accomplished through providing a high customer service and support by understanding how to help the teams be successful. In addition, this role will be responsible for helping update dictionaries, folder structures and other business processes within a QMS technology.

Responsibilities:

* Serve as a primary point of contact for control of client Health documentation including Manuals, Policies, Procedures, Work Instructions, Training Materials, Records, Forms and Templates * Support the technical aspects of QMS systems such as onboarding users, folder structure changes and basic updates. * Provide user training for systems * Ensure compliance of document control processes with client Health SOPs and Work Instructions * Provide administrative oversight to the document control processes so document owners can appropriately and efficiently use client Health document management tools including; review of change orders prior to routing, sending notifications to approvers to ensure timely document review, prepare and release final versions of documents, and review and upload records. * Provide training to new client Health employees on the Document Control processes and associated tools. * Provide technical process / tool support where requests to client Health employees regarding document control and management. * Support regulatory, 3rd party and internal audits by gathering documents, records and change orders including electronic audit trails * Help establish and maintain metrics regarding the compliance and effectiveness of the Document Control process. * Maintain SOPs, Work Instructions and Forms associated with the Document Control process to ensure they represent current practices. * Participate/lead in validation of electronic Document Control tools.

Skill/Experience/Education

Mandatory:

* 5+ years of experience in electronic Document Administration in a Medical Device, Pharmaceutical or Biotech company. * Experience with common document creation / editing tools such as Word, Excel, Acrobat, Powerpoint, Google Docs, Sheets, and Slides. * 3+ years of experience with using and managing electronic document management tools that incorporate automated workflows. Examples include: AODocs, EtQ, Pilgrim, Windchill, Cara, TCU, Trackwise. * Excellent interpersonal skills working across multiple divisions and sites and external resources. * Strong customer service orientation and corresponding skills. * Excellent written and verbal communication skills.

Desired

* Bachelor's Degree * 5+ years of experience in electronic Document Administration in a Medical Device, Pharmaceutical or Biotech company. * 2+ years of additional general Quality Assurance experience in Medical Devices.

As an equal opportunity employer, ICONMA prides itself on creating an employment environment

that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual

orientation, citizenship, or disability.

Keywords: Iconma, L.L.C., Palo Alto , Document and Business Administrator I, Other , Palo Alto, California

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