Job Information

  • Description:

    The Document Control Specialist  works with technical operations, manufacturing, quality control and clinical I regulatory personnel to assure iBio CDMO Document Control (Quality Assurance) policies. The Document Control Specialist  works with the Head of Quality Assurance to implement / enforce Document Control policies, training and compliance programs for company personnel.

     

    Essential Duties and Responsibilities

     

    • Processing and maintaining all current documentation (SOPs, forms, polices, etc.) and archives within the company

    • Provide assistance with editing, formatting and final drafting of SOPs as requested and approved by supervisor.

    • Tracking changes within the manufacturing processes

    • Assist with reviews and edits to documentation as needed.

    • Processing and maintaining all training records within the company

    • Reviewing SOP, Forms, etc. prior to the document going live

    • Supports and maintains documentation for the preventative maintenance program

    • Supports the quality management system for the company

    • Supports the QA functions of internal audits and CAPAs

    • Assists in the conducting and coordinating of internal audits

    • Assist with customer/external audits in retrieving documents and supplying them to the audit team in a timely/urgent manner

    • Work with other QA Manager to develop statistical analyses for documentation processes and data capture relevant to the Quality Systems function

    • Training of employees on records management procedures and polices, which includes documention, retention, retrieval,

    • Assist in daily operational issues, as needed

    • Enhance skills via regular training and continuing education

    • This position will keep confidential all laboratory data and business informationOther duties deemed necessary; be flexible

     

     

     

  • Position Reports To: QA Manager
  • Location: Bryan/College Station, TX
  • Starts On: Jan. 19, 2017, 3:02 p.m.

Job Requirements

  • Experience:

    • Bachelor's degree and 2+ years related work experience in quality and/or regulatory systems development.
    • Fluency in English is essential.
    • Significant work experience using standard Microsoft Office software
    • Experience applying statistical tools/models for trending analyses, metrics reporting, etc.
    • Must be easily adaptable to changing priorities and deadlines, be well organized, articulate, and possess good writing skills
    • ASQ Auditor certification (preferred)

  • Skills:

    • Knowledge of cGMP manufacturing, preclinical pharm/tox and clinical trials.
    • Computer data entry and database management skills
    • Advanced communication and organizational skills
    • Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
    • Attention to details and accuracy
    • Ability to read, analyze, and interpret technical procedures and/or governmental regulations
    • Self-directed and the ability to work independently and highly motivated.
    • Ability to work in a fast-paced and deadline driven environment.
    • Experience working in a GMP environment preferred

  • Computer Skills:

    • Significant work experience using standard Microsoft Office software
    • Experience applying statistical tools/models for trending analyses, metrics reporting, etc.

  • Education Required:

    • Bachelor's degree and 2+ years related work experience in quality and/or regulatory systems development.
    • ASQ Auditor certification (preferred)

Company Information

  • iBio CDMO
    8800 HSC Parkway
    Bryan Texas 77807
    United States of America

Contact Information

  • Jayme Stanley
    Phone: (979) 218-7871
    ibiocmo.com
  • Contact Method:

    Email