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Norwood, United States LS Solutions Full timeRole: Technical writer (Facility & Utility Systems)Location: Norwood, MA, 02062, OnsiteDuration: 3-month contract to start, with potential for extension Job Description:Work with the Facilities & Utilities Departments, and onsite quality and regulatory groups to define and address all issues of non-compliance.Write, revise, and implement SOPs for utility and...
Technical Writer
1 month ago
3 Month Contract
Key Responsibilities:
- SOP Development and Management: Write, revise, and implement Standard Operating Procedures (SOPs) for utility and facility systems. Ensure all documentation is clear, accurate, and compliant with regulatory requirements.
- Compliance Documentation: Collaborate with the Facilities & Utilities team, as well as onsite quality and regulatory groups, to document and address issues of non-compliance. Develop documentation that supports continuous improvement in regulatory adherence.
- Collaboration with SMEs: Work closely with in-house Moderna Subject Matter Experts (SMEs) to gather technical information, develop protocols, and create training materials. Ensure that all documentation accurately reflects the knowledge and expertise of the SMEs.
- Quality Assurance: Ensure all written materials meet high standards of quality, clarity, and accuracy. Review and edit documents for consistency, grammar, and style.
- Additional Duties: Perform additional writing and documentation tasks as needed and as directed by Patricia Rivera-Falcon or her designee. This may include supporting various projects, participating in team meetings, and contributing to the overall success of the department.
Required Qualifications:
- Experience: 3-5 years of experience in technical writing, preferably in a regulated industry such as biotechnology, pharmaceuticals, or medical devices.
- Technical Skills: Strong ability to understand and document complex technical systems, particularly in facilities and utilities contexts.
- Writing and Editing: Proven experience in writing and revising SOPs, technical manuals, and training materials. Excellent command of English grammar, style, and formatting.
- Collaboration: Strong interpersonal skills with the ability to work effectively with cross-functional teams, including quality assurance, regulatory, and technical experts.
- Attention to Detail: Exceptional attention to detail, with the ability to ensure accuracy and consistency in all documentation.
Preferred Qualifications:
- Experience with utility systems and facility management documentation.
- Familiarity with GMP (Good Manufacturing Practice) environments and associated documentation standards.
- Experience working on-site in a highly regulated environment.
