LSNE - Madison, LLC
  • Madison, WI, USA
  • Full Time

JOB SUMMARY -

Manage, coordinate, and maintain CGMP documentation, electronic and/or paper based, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived.

JOB DUTIES -

  • Facilitate Document Change Requests and Master Documents within electronic Document Management System (eDMS)
  • Maintain Designated Satellite Areas for controlled record management systems
  • Facilitate Client Batch Record Creation/Modifications/Approvals
  • Issue, maintain and archive Controlled Documentation/Batch Records/Testing Data Sheets/Equipment Log Books/Quality System event documents and Logs
  • Provide support for proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Gather metric information for use in continuous improvement activities
  • Track and facilitate Periodic SOP reviews
  • Manage Record/Document Filing system including scanning of executed records
  • Proof and edit document changes, as necessary
  • Assist in client audit preparation and reconciliation
  • Other duties as assigned

EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE -

  • High School Diploma/Associates degree with a minimum of 5 years in a cGMP Environment; 1 year previous experience with Bachelor's degree
  • Exceptional planning and organizational skills and the ability to multi-task and meet deadlines in a fast-paced team environment
  • Detail oriented
  • Proficient in Microsoft Office (Word, Excel, and Access required; PowerPoint is a plus) for data processing and spreadsheet creation and maintenance
  • Prior experience working in a 21 CFR Part 11 complaint eDMS highly preferred
  • Strong internal customer service/people skills are required
  • Excellent professional verbal, written, and communication skills are required
  • Working knowledge of FDA (21CFR 210 and 211) and EU regulations a plus, but not required

 PHYSICAL REQUIREMENTS

  • Requires the ability to communicate effectively using speech, vision, hearing and written word
  • Requires bending, squatting, climbing, reaching
  • Requires the ability to lift, carry, push or pull light weights (up to 20 pounds)

COMMUNICATIONS & CONTACTS

        Interacts with all cross-functional departmental staff

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -  Not Applicable

LSNE - Madison, LLC
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