Technical Writer

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: