Document Control Lead

Job Locations US-TX-College Station
Posted Date 3 months ago(1/17/2020 10:01 AM)
Requisition ID
Quality Assurance
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies U.S.A., Inc.


Summary:  This is an experienced role with in-depth and specialized knowledge of cGMP documentation.  This position can largely function with minimal or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, maintaining Document Control KPIs, etc.  Additionally, the Document Control Lead will establish and modify comprehensive document control systems that are compliant with cGMP requirements, as well as assist in preparation for and help with quality audits.  This role provides technical knowledge and leadership for the team and may act as a Quality representative in certain situations when necessary.

External US

Essential Functions:

  • Function as SME for document processing protocols, regulations and best practices.
  • Handle scheduling and coordination of internal departmental projects.
  • Tracks documents during the routing, review and approval process.
  • Facilitates communication and develop internal KPIs to ensure team is on target to meet expectations.
  • Assist with review of basic documentation to include, but not limited to:
    • Standard Operating Procedures
    • Corrective Action/Preventive Action Plans
    • Data Reports
  • Assist in Quality audits to include, but not limited to:
    • Audit of lab notebooks
    • Audit of equipment logbooks
    • Review of vendor, supplier, contract laboratory audit questionnaires
  • Assigns effective dates to approved controlled SOPs, PRs, and policy documents.
  • Participates in regulatory inspections when needed.
  • Assists with inspection of final product containers and review and/or approval of executed process records and data.
  • Identifies and develops necessary internal training as appropriate.
  • Plans team daily work activities, and provides technical training to existing and/or new employees.
  • Assigns personnel to assist with functions at NCTM, TBF100, or FBF200.
  • Acts as Document Control EDMS system administrator.
  • Departmental oversite of Document Control processes and procedures.
  • Administrator/Owner of site Document Control Archive.
  • All other duties as assigned.


Required Skills & Abilities:

  • Excellent written and oral communication skills.
  • Perform as a SME for Document Control.
  • Strong attention to detail.
  • Ability to multitask and prioritize work assignments with little supervision.
  • Demonstrated ability to work collaboratively in resolving inquiries and responding to problems and/or complaints from employees, vendors, customers, etc.
    • Strong organizational skills.
  • Demonstrated Leadership Abilities
  • Strong understanding of pharmaceutical manufacturing systems, processes and terminology strongly preferred.
    • Experience with Word, Excel, and Adobe.


Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged sitting, some bending, stooping and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Ability to access and utilize computer interfaces for extended periods of time
  • Attendance is mandatory.


Minimum Qualifications:

  • Bachelor’s degree preferably in a Scientific discipline; or related field and 2+ years of Document Control experience supporting cGMP documentation in a Pharmaceutical, Biotechnology or Contract Laboratory environment; OR
  • Associate’s degree preferably in a scientific discipline; or related field and 4+ years of Document Control experience supporting cGMP documentation in a Pharmaceutical, Biotechnology or Contract Laboratory environment.


Preferred Qualifications:

  • Strong understanding of pharmaceutical manufacturing systems, processes and terminology strongly preferred.


We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.


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