What are the responsibilities and job description for the Technical Writer position at Ingenics Corporation USA?
Overview
The Technical writer role is intended to support the clerical aspect of Good Manufacturing Practices (GMP) through document drafting, updating, routing, and coordinating the timing of these activities against business needs.
These documents may support any aspect of the total manufacturing process including—but not limited to—Master Batch Production Records, Material Specifications, Procedures, Work Instruction, Protocols, and Forms.
Maintain a level of ownership of site supporting systems including document control system, quality management systems, network drives, software based organizational channels, etc.
Responsibilities
- Responsible for the areas of workplace safety, training, environmental compliance, adherence to quality process/procedures, and area housekeeping.
- Responsible for tactical batch execution readiness including (but not limited to) initiating / coordinating change controls in quality systems, executing document generation / revisions, oversee document reviews / approvals in document management systems, and drive other groups to complete their portions within this process.
- As needed, responsible to provide clerical review of executed batch records and other completed documents for adherence to site quality standards.
- Any other assigned job tasks as assigned by management
- Responsible for strategic batch execution readiness including (but not limited to) providing updates in planning meetings regarding forecasted timelines, looking many months in advance to ensure readiness steps beginning in a timely manner, area performance trending / reporting, post process continuous improvement through after-action review, and other process improvement duties as needed to achieve functional objective and targets.
- Seek out and identify opportunities for improvement in the areas of GMP document management, training, execution, deviation causal factors, and product release
- Contribute to Departmental metrics data entry; Area and unit operation process performance trending / reporting Short term reduction in document related delays and establishment of sustainable systems to support long term operational excellence.
- This function has the potential of being extended to overseeing other systems including ownership of managing quality system records to ensure timely execution of work.
Requirements
- Degree (Preferably BA/BS) in STEM subject and/or where technical writing is required
- Excellent written, verbal, organizational, and people skills
- Proficient in Microsoft Word. Basic understanding of all other Microsoft Office software.
- Ability to learn enterprise computer based software (e.g. Regulus, TrackWise, SAP, etc.)
- Ability to interact and communicate effectively with production operators and senior management regarding aspects of past, present and future manufacturing unit operations and improvements
- Ability to display competent level understanding of operational requirements for cleanrooms in highly regulated environment pharmaceutical
- Ability to multi-task and manage complicated, dynamic manufacturing activities in multiple locations on time and on/under budget while also managing other job-related tasks/activities
- Relevant industry experience in GMP style environment
- Preferred: Basic knowledge of the scientific principles pertaining to standard processing and manufacturing equipment.