Technical Writer

Description

Location: Seattle-Dexter

Hybrid – (Flexible days – 50% + onsite)

Top Skills:

• Bachelor’s degree required - Life Sciences degree preferred
• Minimum of 1-3 years’ experience in a GMP environment.
• 1-3 years’ experience with GMP labelling is preferred.
• Experience with Oracle and/or SAP preferred.

POSITION SUMMARY

• 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 team meetings, Share point, EDMS. Able to conduct video conference calls via MS teams 4-6 hours a day.
• Bachelor’s degree required - Life Sciences degree preferred