Document Control Coordinator

LNK International Inc. is one of the nations largest manufacturers of solid and liquid dose over the counter (OTC) pharmaceuticals. For over 40 years we have built a reputation for delivering the highest quality products outstanding service and product innovation.

What sets LNK apart We believe it is our employees. There is a commitment to quality in every department at LNK. As a member of our Regulatory Compliance Department and QA team you will be part of a team of dedicated professionals who support and interact with all areas of the company.

Our full time employees enjoy competitive benefits including:

• 401(k) with generous employer match
• Health Insurance
• Dental Insurance
• Paid holidays
• Paid vacation

Shift: Day Shift

• Position requires an associate degree or related experience.
• Minimum 1 year experience in an equivalent role within an FDA regulated pharmaceutical environment preferred.

• Areas of Responsibility:
  • Provides ongoing and timely support of document control and records management.
  • Tracks all stages of issuance review approval distribution and archival of documents.
  • Change Control responsibilities include:
    • Maintain Change Control Log
    • Review Change Controls for completeness
    • Route Change Controls
    • Check/Archive Closed Change Controls
  • Cleaning & Working Logbook responsibilities include:
    • Notify necessary parties when a logbook is expiring
    • Create new logbooks
    • Issue replacement logbooks
    • Archive returned logbooks
    • Maintain the logbook numbering systems
    • Maintain PDFs of logbooks for issuance purposes
  • Procedure (SOPs/QCOPs/WIs/etc.) responsibilities include:
    • Issue/maintain new procedure numbers
    • Prepare training copies
    • Maintain Electronic Copies
    • Put procedures into effect
    • Maintain Master Book(s)
    • Maintain Electronic folder(s)
    • Update SOP Books throughout the buildings
    • Archive obsolete revisions
    • Maintain 2-Year Review spreadsheet
    • Maintain Cross Reference Sheet
    • Maintain Standard Master Forms folder
  • Organizational Projects including periodic reviews of
    • Procedure Books
    • Electronic copies of procedures
    • Procedure Index titles
    • Training Copy folder
    • Site Procedure Book folders
    • Standard Master Forms folder
  • Maintains and files all master documentation.
  • Performs all responsibilities in accordance with company policies SOPs and all regulatory standards and regulations.
  • Follows all safety procedures policies and precautions.
• Required Skills and Abilities:
  • General computer knowledge/skills (Microsoft Windows typing emailing file management navigating folders/network drive).
  • Proficient in Word and Excel.
  • Knowledge of Outlook and PowerPoint.
  • Knowledge of Adobe Acrobat.
• Physical Requirements:
  • Limited lifting (40-50 pounds).
  • Ability to sit at a workstation for multiple hours.
• Work Environment:
  • Fast-paced office

The above statements are intended to describe the general nature and level of work being performed by the personnel assigned to do this job. They are not intended to be an exclusive list of all responsibilities duties and skills required.

The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team members base salary and/or rate several factors may be considered as permitted by law.

LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth and pregnancy-related conditions) gender identity or expression (including transgender status) sexual orientation marital status military service and veteran status physical or mental disability genetic information or any other characteristic protected by applicable federal state or local laws.

Required Experience:

IC