Job Description

Job Description

Job Title: Document Control Specialist I
\n Location: Onsite | Medina NY 
\n Schedule: 8:00 AM – 4:30 PM, Monday – Friday
\n Pay Rate: $21.00/hr\n \nAbout the Role\nWe are seeking a diligent and detail-oriented Document Control Specialist to join our team. This onsite position is a vital component of a manufacturing operation, supporting the management and integrity of our documentation systems. If you thrive in a regulated, team-oriented environment and have strong clerical and organizational skills, we’d like to meet you!\n\n \nKey Responsibilities\n\n

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• Provide clerical and administrative support for Quality Assurance document control systems in compliance with current Good Manufacturing Practices (cGMP).\n\t
• Perform electronic archival of Manufacturing Device History Records (DHRs), including:\n\t \n\t\t
• Scanning, verification, archival, and transfer of DHRs in accordance with established procedures.\n\t\t
• Preparation of records for scanning (removing staples, accurate pagination, compiling device serial numbers, and software versions for transfer).\n\t\t
• Scanning DHRs with dedicated equipment and applicable software.\n\t\t
• Verifying scanned records to ensure they are true, clear, complete, and legible copies.\n\t

• Archive or destroy records per Records Retention Schedule and established procedures.\n\t
• Troubleshoot document scanner issues as needed.\n\t
• File and archive records, including maintenance and transfer to offsite storage.\n\t
• Perform other administrative duties as assigned.\n\n\n \nQualifications & Skills\n\n
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  • High school diploma or equivalent required.\n\t
  • 1–2 years of office experience preferred.\n\t
  • Working knowledge of computer operations and familiarity with Microsoft Office Suite.\n\t
  • Basic knowledge of office equipment and word processing.\n\t
  • Excellent verbal and written communication skills.\n\t
  • Exceptional attention to detail and ability to prioritize workflow.\n\t
  • Strong organizational skills with the capability to multitask and perform tasks efficiently with minimal supervision.\n\t
  • Ability to identify errors/faults in the process and escalate appropriately.\n\t
  • Responsive to customer and team needs within job scope.\n\t
  • Ability to follow directions and complete routine tasks per guidelines.\n
  \n\n \nPhysical Demands\n\n
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  • Must be able to sit, stand, bend, stretch, and walk throughout the workday.\n\t
  • Must be able to lift at least 25 lbs.\n\t
  • Ability to work effectively under tight deadlines.\n
  \n\n \nWork Environment\n\n
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  • ONSITE role in a manufacturing environment regulated by the FDA and other quality standards.\n\t
  • Static protective smocks and Personal Protective Equipment (PPE) must be worn at all times in designated areas.\n\t
  • Work closely with other employees in temperature- and humidity-controlled settings.\n\t
  • Reasonable accommodations will be made for individuals with disabilities.\n
  \n\n Ready to join a leading team in the medical device industry? Apply now to become our next Document Control Specialist!
  

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  \n\t\t\t\tAs part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
  
  

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