Qa Document Control Coordinator

LNK International, Inc. is one of the nation's 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

Responsibilities:

Responsibilities include but are not limited to:

• 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
  • Notify necessary people when finished product specification sheets is obsolete/effective and update Master Book and electronic folder.
  • Cleaning and Working Logbook responsibilities including: Notify necessary parties when a logbook is expiring, create new logbooks, issue replacement logbooks, archive returned log books, maintain the logbook numbering systems an maintain PDF's of logbooks for issuance purposes
  • Procedure responsibilities include:
    • Issue/maintain new procedure numbers
    • Prepare training copies
    • Maintain electronic copies
    • Put procedures into effect
    • Maintain master book
    • Maintain electronic folders update SOP books throughout the buildings
    • Archive obsolete revisions
    • Maintain 2 year review spreadsheet
    • Maintain cross reference sheet
    • Maintain standard master forms folder
• • In person. There is no remote option for this role.
  • Fast paced, office setting.
  • Overtime may be required from time to time.
  • Prolonged periods of sitting and computer work
  • Limited lifting
    • Organizational projects including periodic reviews of procedure books, electronic copies of procedures, procedure index titles, training copy folder, site procedure book folders and standard master forms folder
    • Maintains and files all master documentation
    • Performs all responsibilities in accordance with company policies, SOP's and all regulatory standards and regulations
    • Follows all safety procedures, policies and precautions
    • Must be able to work overtime as needed.
    
    

    Required Knowledge, Skills and Abilities:

    • General computer knowledge/skills
    • Proficient in Word and Excel
    • Knowledge of Outlook, PowerPoint and Adobe Acrobat
    
    

    Education and Experience:

    • Associate's Degree (business preferred) or equivalent experience
    • Minimum 1 year experience in an equivalent role within an FDA regulated pharmaceutical environment preferred.
    
    

    Work Environment:

  
  
  • Fast paced, office setting.
  • Overtime may be required from time to time.
  • Prolonged periods of sitting and computer work
  • Limited lifting
  
  

  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 member's 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.