Federation of American Societies for Experimental Biology (FASEB)

Documentation Specialist I/II

AGC Biologics
Longmont, Colorado, United States
11 days ago

Description

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY
The Document Control Specialist’s primary responsibilities include activities related to the identification, collection, distribution and filing of controlled documents.   Key contributions include writing, revising and maintaining document control procedures and participation in the development and deployment of document control tools.



Requirements

PRINCIPAL RESPONSIBILITIES:

  • Ensure that released documentation supporting manufacturing and quality, is current, accurate, and processed in a timely manner.
  • Issue production batch records and labels for manufacturing operations.
  • Serve as secondary point of contact for documentation and records.
  • Provide support for the development and maintenance of site documentation, procedures, work instructions, and templates.
  • Maintain the document storage room, and manage off-site archiving of documents.
  • Create and approve document change requests, manage document workflows, and release documents
  • Write and maintain document control procedures.
  • Participate in the development and roll-out of document control tools.
  • Follow policies, SOPs and work instructions to support the document approval process.
  • Develop and deliver training regarding document control processes and system changes.
  • Execute the process for identifying, collecting, distributing, and filing controlled documents for the satellite files.
  • Support internal and external audits and regulatory inspections.
  • Perform routine and ad hoc document control metric reporting and analysis.
  • Monitor documentation system function; investigate and coordinate with IT on issues.
  • Provide communication of the status of deliverables to customers, management, and stakeholders.
  • Work on complex documentation problems, analyzes procedures and data to create appropriate solutions.
  • Additional responsibilities not listed may be required of this position.

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to exercise judgment within defined practices and policies in performing document control functions with input from supervisor.
  • Ability to conduct work within limits of defined practices and procedures.
  • Ability to work on several concurrent projects at the same time.
  • Ability to work independently on routine work tasks, and under only general instructions on new assignments.
  • Ability to interact constructively and efficiently with co-workers within and across departments.
  • Demonstrated deep understanding of basic documentation concepts.
  • Deep understanding of cGMPs and quality systems.
  • Experience with relevant software and databases.
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.

EDUCATION/EXPERIENCE:

  • AA or BS in science-related field desired; combination of education and related work experience required
  • 3 – 5 years of QA or related document control experience required
  • Previous Quality Systems Administration experience required
  • Experience with relevant software and databases required (e.g., MasterControl Document Management System, TrackWise)
  • Experience interacting with FDA or other regulatory agencies preferred.

COMPENSATION RANGE:
$53,400- $74,472 annually


AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any
other characteristic protected by applicable laws, regulations and ordinances

Job Information

  • Job ID: 58633775
  • Location:
    Longmont, Colorado, United States
  • Company Name: AGC Biologics
  • Position Title: Documentation Specialist I/II
  • Job Function: Adminstrator,
    Bioinformatic Scientist,
    Biologist,
    Biomedical Equipment Technician,
    Biomedical Repair Technician
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: Associates Degree
  • Min Experience: 3-5 Years
  • Salary: $53,400.00 - $74,472.00 (Yearly Salary)
Biotechnology
Boulder , CO , US

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast track projects for orphan drugs and rare diseases.   AGC Biologics purchased a state-of-the-art commercial m...

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