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Document Administrator - GMP
6 days ago
Contract
Wilson, North Carolina, US

Job Description

Qualifications:

Core Competencies/Leadership Behaviors/Skills – Must Haves:

  • Excellent typing skills – formatting, spelling, etc.
  • Ability to coordinate, log, track, and follow-up on outstanding items
  • Self-motivated with a strong sense of urgency to meet timing requirements
  • Work must be accurate and properly documented for GMP purposes
  • Must be able to manage multiple tasks day to day
  • Ability to achieve objectives requiring a high level of cooperation from others throughout the organization
  • Must be able to prioritize tasks based on deadlines and schedule changes Organization skills 2-3 years of prior document management experience. Extrordinary Attention to detail Can manage multiple priorities without sacrificing quality
  • Education - High School Diploma Prioritize workload and be able to multitask to work efficiently with little supervision
  • Support the use of team sites
  • Complete work assignments using independent judgment Maintain a level of confidentiality You are a team player, collaborative, you are organized and can juggle multiple priorities. You have great interpersonal skills/abilities and get along with everyone.
  • There are 5 to 6 people on the very collaborative team. The leading manager is hands off. Certainly always there to help. Expectation is that team/individuals will manage priorities. 

Preferred Skills:

  • Quality Management systems, cGMP, and regulatory inspections
  • Excellent technical writing skills
  • Detailed Oriented
  • Learning and Development
  • Project Management
  • Problem Solving MIDAS / SharePoint (Team site usage) Pharmaceutical industry experience preferred VeevaDocs experience is negotiable (preferred).
  • Advanced MS Word experience.
  • Teams experience useful. iOS platform experience Electronic SOP experience.
  • Resume red flags - Formatting errors, odd fonts, spacing, spelling.

Responsibilities:

Standard Operating Procedure management core responsibilities include:

  • Creating and formatting SOPs, Setup Sheet templates, Work Instructions, Forms, Job Aids and TBS documents
  • Maintaining SOPs, Setup Sheet templates, Work Instructions, Forms, Job Aids and TBS in electronic repository (QualityDocs)
  • Tracking Review and Approval Processes within QualityDocs (As needed)
  • Managing distribution of setup sheets and Job Aides to packaging lines
  • Maintaining the Central SOP/Setup Sheet and Flowchart hard copy Libraries – current
  • Managing documents per records retention requirements and identifying Legal Holds
  • Managing MMD-Wilson Procedures Workgroup in QualityDocs
  • Cascading communications for SOP Training
  • Updating New & Revised SOP URLs with current Effective Dates and Training Requirements in myLearning
  • Manage SOP 3-year review processes for SOPs and Flowcharts
  • Champions the Topic 1.3 subsystem, SOP Management, ensuring site alignment. Monitors system health and identifies system improvements.
  • Learning and Development core responsibilities:
  • Utilizes and maintains site training data within the Learning Management System (LMS), or other authorized tools, to manage and monitor training inputs, materials, and reports.
  • Performs training data entry functions within the LMS and maintains hardcopy training completion data, including archives.
  • Assists L&D Specialist with material reproduction and training room scheduling and setup as needed Candidate will be assisting team bring on a new document management technology; VeevaDocs.
  • Transitioning from SharePoint to VeevaDocs.
  • Once transitioned, candidate will work to categorize documents.
  • From there, they will work with various teams/Workflow approvers on links, retirement histories and other document related archival policies.

Job Requirements

Excellent typing skills, documentatation, document management, technical writing

 

Job Code: 50124808

Reach Out to a Recruiter

Recruiter Kajal
Email
Phone +9738057541