Description Overview
The Technical Writer is responsible for the development, creation, and revision of controlled documentation using the OpenText System in accordance with Perrigo policies and procedures and current GMP practices. The Technical Writer will partner with Quality department, other cross functional managers/supervisors, and engineers to ensure that controlled documents being revised contain the correct information. Additionally, the role will provide support for maintaining the Learning Management System (LMS).
The salary range for this role is between $75,000 to $80,000
Scope of the Role
- Support/Train functional departments and subject matter experts in the creation and revision of the following cGMP documentation to optimize processing and ensure alignment with current practices utilizing the OpenText system:
- Standard Operating Procedures
- Standard Work Instructions
- Training Completion Statements,
- Job Aids
- Controlled Forms
- Execute tasks associated with LMS administration, including but not limited to the creation and maintenance of:
- Creates and maintains GMP curricula, courses, and items.
- Enter training records in the LMS system or using the ATA system
- Generate and track the audit of each curriculum working with department heads or curriculum owner
- Provides training reports , training material and metrics as requested for compliance to support FDA audit, internal/external audit and miscellaneous requests.
- Recognizes and resolves training discrepancies, reaches out to Global training and communicates corrective action to affected personnel.
- Review cGMP documentation for standardized formatting, technical accuracy, clarity, grammar, and spelling.
- Select and edit images/videos (photographs, diagrams, technical drawings) to enhance training materials.
- Files all training documentation (hard copy) and provides general administrative support for the department as required.
- Excellent understanding and working knowledge of PC and Microsoft applications (Microsoft Office) and presentation tools (PowerPoint).
- Details oriented with the ability to multi-task and meet deadlines as well as strong interpersonal and team building skills.
- Strong organizational skills, flexibility, and ability to work independently.
- Administration duties:
- Member of the site committees
- Ordering supplies/decorations, lunches, catering
- Utilizing the RedZone system to post communication, recognition and site event
- Oversee the Company store, working with Operations, Manufacturing and Warehouse with scheduling of employees
Experience Required
- Bachelor’s degree.
- 2 or more years of relevant systems experience required in a regulated industry, preferably in Life Sciences.
- Learning Management System (LMS).
- Understands the application of GMP concepts and understands 'why' behind the regulations.
- Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry
- Comprehensive working knowledge of OpenText, Microsoft suite, including Outlook, Teams, Word, Excel, PowerPoint, SharePoint
