Technical Writer
2 weeks ago
Sunrise System Inc. is currently looking for Technical Writer in Bothell, WA with one of our top client.
Job Title: Technical Writer
Job Id: 24-00408
Location: Bothell, WA 98021
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
TOP SKILLS:
- 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, communication and customer service skills.
Key Responsibilities and Major Duties
- 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 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, 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 SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
- Work independently but recognize need to consult stake holders 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.
Requirements
- 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 Share Point.
- Proficient in Microsoft outlook, MS team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
The hourly rate for this position is between $57-$63 per hour.
Compensation:
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact
Satya | Sr. Delivery Manager
Direct: |Email:
-
Senior Technical Product Manager
6 days ago
Bothell, United States GE Vernova Full timeJob Description SummaryHelp us revolutionize the power grid and the energy we use through smart grid technologies. As our new Senior Technical Product Manager, you will be responsible for creating strong working relationships and influence across product management, engineering, services, sales and other functional groups, to contribute to the definition and...
-
Senior Technical Product Manager
4 days ago
Bothell, United States GE Vernova Full timeJob Description Summary Help us revolutionize the power grid and the energy we use through smart grid technologies. As our new Senior Technical Product Manager, you will be responsible for creating strong working relationships and influence across product management, engineering, services, sales and other functional groups, to contribute to the definition...
-
Computer Validation Specialist
2 weeks ago
Bothell, United States Sunrise Systems, Inc. Full timeSunrise System Inc. is currently looking for Technical Writer in Bothell, WA with one of our top client. Job Title: Computer Validation SpecialistJob Id: 24-00408Location: Bothell, WA 98021Duration: 12 months Position Type: Hourly contract Position (W2 only) TOP SKILLS:3-5+ years experience in performing periodic review of computerized systems.Experience in...