Technical Writer
3 weeks ago
Responsibilities:
Provide support for Parenteral Operations by researching, organizing, writing, editing, and formatting technical information to produce high-quality documents.
Key Objectives / Deliverables:
- Creating and revising standard operating procedures, work instructions, forms, and other controlled documents to communicate complex technical information in a clear and concise manner.
- Perform gap assessments between global and local procedures to identify areas that require remediation or continuous improvement.
- Utilize completed gap assessments to revise or create controlled documents.
- Collaborating with subject matter experts and technical staff to create or revise controlled documentation.
- Ensuring that the written content meets the needs of its intended audience.
- Responsible for the timely closure of assigned quality records.
- Serve as document administrator within the electronic Quality Management System (eQMS), MasterControl.
- Process document changes and management of changes while ensuring good documentation practices (GDP) within the eQMS, MasterControl, and compliance to Nexus Pharmaceutical’s procedures.
- Perform initial change control requests for proper workflow and change control documentation requirements within MasterControl.
- Act as contact person for troubleshooting record workflow through MasterControl change control process.
- Perform document control review following area manager and QA approval to ensure proper formatting.
- Launch new documents within MasterControl to assist with document change control lifecycles.
- Manage and ensure compliance to record retention policy.
- Schedule and track the periodic review of controlled documents.
- Maintain and issue logbooks to Operations, Engineering, Micro/QC Laboratories as needed.
- Maintain, issue, and reconcile serialized forms.
- Other duties as assigned.
Basic Requirements:
Education
- 4-year bachelor’s degree in science-related strongly preferred. (Additional GMP Quality Experience may be accepted in lieu of degree)
Experience
- 3+ years of relevant experience. Pharmaceutical preferred.
- Knowledge of Microsoft Office Suite Programs required.
- Familiarity with digital QMS systems, MasterControl preferred.
Additional Skills/Preferences:
- Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
- Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
- Must be able to work independently
- Strong organizational skills
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