Allentown-Bethlehem-Easton Metro Area, Pennsylvania
- Responsible for designing, developing, and updating required technical documentation.
- Responsible for technical writing/editing for all types of documentation produced within a modern software development environment.
- Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
- Documents programming standards and procedures.
Execute daily activities that support training compliance and traceability to all executed activities in a highly collaborative manner, with both internal and external cross functional team members and site customers to ensure timely deliverables of a modernized and continuously improved training curriculum
Build and author revisions to existing training documentation for the shopfloor scientific processing areas. Author new training materials as required to support continuous improvement activities.
Provide data for functional area metrics such as: documentation throughput, time/task analysis, site training compliance, etc. with objective to identify and/or improve system compliance and/or process challenges
Achieve and maintain SME status on all functional area application systems and reporting tools suchas, ISOTRAIN, Documentum, Microsoft applications, eDOC, etc .
Participate in GEMBA walks and shopfloor auditing activities to help the areas maintain their state of compliance.
Provide end user training for all systems related to the department output objectives, this includes becoming a Qualified Trainer as appropriate and delivering training to new and existing employees across multiple levels.
- Accountable for the execution of daily activities as related to training program execution and delivery, maintenance of training compliance and maintenance of training content.
- Contribute to organizational knowledge management on all technical and paper based systems that support daily activities of training program management and content,
- Responsible to provide back-up support to other areas at the Swiftwater site on an as needed basis.
- Evaluated on the performance of the key activities and the degree to which obstacles to success are identified and resolved.
- Cross functional collaboration is a key indicator of commitment to improving internal and crossfunctional processes. Effective and professional communication skills across diverse labor pools are required.
Education and experience
- Bachelor s degree preferred, and/or 3 or more years GMP experience in documentation and/or training.
- Preferred direct experience working on the shop floor in a GMP environment.
- Strong knowledge of GxP is required.
o Documentation maintenance and creation
o Record Mgmt.
o Quality systems as relevant to executed activities
Competencies (LEAD model)
Motivation for right first time approach to all deliverables
Key technical competencies and soft skills:
- Must be proficient in Microsoft Office applications.
- Demonstrate SME level understanding of functional area electronic business systems and adaptability to learn new systems/processes.
- Critical thinking skills are a must in order to develop strategies and/or enhance business practices and desired outcomes. Peer to peer and upward communication professional business communication skills required.
- Ability to train and teach diverse groups of shopfloor personnel.