Jobs · Administrative · Indiana

Documentation Specialist

Simtra BioPharma Solutions · Bloomington, IN · 1 mo ago
On-siteAdministrativeFull-time

About the role

The Documentation Specialist assists in preparing and/or maintaining Quality System documentation including standard operating procedures (SOPs), forms and logbooks. This role also assists the site's Subject Matter Experts in the execution of document change control. This position reports to a Quality Supervisor or Manager.

Responsibilities

  • Reviews, process and releases Quality related documents using the EDMS system. The review ensures documents and change management are compliant with site procedures.
  • Coordinates Periodic Review process.
  • Maintains and modifies related department procedures as needed.
  • Generates and maintains performance reports and related metrics.

Qualifications

  • High school diploma required. Associates degree preferred.
  • Minimum 2 years experience with documentation and/or change control systems.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, TrackWise, etc.)

Physical / Safety Requirements

  • Occasionally required to lift and/or move objects (boxes, files, etc.) weighing 25 pounds.
  • Duties may require overtime work, including nights and weekends.
  • Position requires sitting for long hours, but may involve walking or standing for periods of time.
  • Use of hands and fingers to manipulate office equipment is required.

Benefits

  • Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
  • Onsite Campus Amenities: Workout Facility, Cafeteria, Credit Union
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