System One
System One is hiring: Technical Writer in Seattle
System One - Seattle, WA, United States, 98127
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Overview
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Overview
Job Name: Technical Writer
Location: Seattle WA 98109, Hybrid 50% onsite
Type: Contract
Pay Rate: $42.64 - $54.16/ hr
Job Description:
The Technical Writer will manage and oversee data input and documentation management and functions as detailed below to ensure delivery of Cell Therapy labelling projects.
Key Responsibilities and Major Duties:
- Write and revise standard operating procedures (SOPs) and specifications for GMP Labelling operations.
- Complete intake forms and follow up on item creation process with cross functional stakeholders.
- Ability to interview cross functional subject matter experts and translate their description into actionable instructions - Work Instructions, Job Aids using the templates prescribed by corporate policy.
- Schedule cross functional team meetings, collect feedback, create draft documents, schedule reviews, collect and resolve feedback.
- Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
- Prepare document periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
- Maintain a good understanding of regulations and other guidelines applicable to GMPs.
Requirements:
- Minimum of 1-3 years experience in a GMP environment.
- 1-3 years experience with GMP labelling is a plus.
- Experience with Oracle and/or SAP a plus.
- Demonstrated ability to successfully manage competing deadlines and balance priorities.
- Ability to track and follow up on multiple workstreams and escalate when appropriate.
- Expertise in Microsoft Word.
- Proficient in Microsoft Outlook, MS Teams, SharePoint, EDMS. Able to conduct video conference calls via MS Teams 4-6 hours a day.
- Bachelor's degree required - Life Sciences degree preferred.
Benefits:
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #568-Clinical
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