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Documentation Specialist II

Oceanside, CA 92056

Posted: 03/09/2023 Employment Type: Contract Industry: Administration Job Number: 11084 Pay Rate: $26.00 - $35.00

Job Description

Our client is a leading biotechnology company that discovers, develops, manufactures, and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

  • The Document Specialist provides document review, retention, distribution and accountability for all documentation related to capital projects and engineering services for commercial and clinical manufacturing related facilities.

  • Format and proofread new and existing documentation for correctness and cGMP compliance.
  • Collaborate with SMEs and other team members in the creation and development of varied documents and procedures.
  • Submit and route documentation for review and approval.
  • Contribute to constant documentation and process improvement.
  • Provide support for routing documents for review and approval.
  • Scan approval pages and upload, as applicable so that dependent activities can proceed.
  • Ensure that project deliverables are tracked and are uploaded to the appropriate
  • locations in appropriate system using the metadata as required.
  • Work with EDC to ensure standards are followed, obtain new document numbers, and ensure that documents are entered into gMMS in time for testing or other dependent activities.
  • Assist team members with locating documents and templates in the applicable systems (Touchpoint, gMMS, PKM, gDocs).

Job Requirements

  • Strong organizational and project coordination skills.
  • Ability to take the initiative in resolving situations as they happen.
  • Proactive solutions oriented capability and ability to multi-task.
  • Ability to manage complex details under tight deadlines.
  • Exceptional attention to detail and quality of work.
  • Ability to work independently and in teams.
  • Ability to manage multiple projects simultaneously.
  • Excellent follow-through and a keen interest in resolving action items.
  • Comfortable interacting with management.
  • Displays professionalism in all internal and external endeavors.
  • Extraordinary communication skills (both written and verbal).
  • Strong work ethic and integrity.
  • Discretion with sensitive/confidential and proprietary information.
  • Advanced skills with Microsoft Office Suite, Excel, PowerPoint and Word.
  • Proficiency with other software applications: Visio, Adobe Acrobat, Google Suite, and others as needed.

Meet Your Recruiter

Melissa Politron

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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