Technical Writer

Job Title: Technical Writer

Location: Bothell, WA

Compensation: $52.00 - $62.29/hr

Type: Contract, Potential for extension or conversion to permanent

Responsibilities

• 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.

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.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.