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.
- 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.
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.
Excellent typing skills, documentatation, document management, technical writing