Job Description
Job Title: Technical writer
Pay: $58.00 - $62.00 / hour
Location: Bothell, WA - 100% onsite - Local candidates only
Term: 12-month contract (possibility of extension/conversion to FTE, depending on performance)
Note: No C2C or sponsorship is provided
Must-have's:
- Minimum of 5-8 years’ experience in a GMP laboratory environment.
- At least 5 years' experience in writing and reviewing standard operating procedures.
- Experience with Veeva EDMS preferred, or similar
- Experience with ERP, SAP Preferred, revising or creating new documents
- Experience working cross-functionally, with communication, and customer service skills.
- Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments.
- Ability to interview cross-functional subject matter experts and translate their descriptions into actionable instructions- Work Instructions and job Aids using the templates prescribed by corporate policy.
- Schedule cross-functional team meetings, collect feedback, create draft documents, post on SharePoint, 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 the SOP periodic review timetable and ensure the review/approval or retirement is completed in support of the procedure lifecycle in a timely manner.
- Work independently but recognize the need to consult stakeholders and keep them informed of progress.
- Identify and lead improvement efforts within current procedures.
- Maintain a good understanding of ICH Guidelines, regulations, and other guidelines applicable to GMPs.
- Ability to negotiate and influence solutions without direct authority.
- A self-starter with an ability to manage electronic systems with minimal training and supervision.
- Minimum of 5-8 years’ experience in a GMP laboratory environment.
- At least 5 years experience in writing and reviewing standard operating procedures.
- Experience with Veeva EDMS preferred, or similar.
- Experience with ERP, SAP Preferred, revising or creating new documents.
- Experience with microbiology testing is a plus.
- Demonstrated ability to successfully manage competing deadlines and balance priorities.
- Excellent technical writing skills, close attention to detail and excellent follow-up.
- Expertise in Microsoft Word and SharePoint.
- Proficient in Microsoft Outlook, MS team meetings, SharePoint, and EDMS.
- Able to conduct video conference calls via MS teams 4-6 hours a day.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
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