Technical Writer

TechDigital Group; Wayzata (MN); On-site; USD 70,000 - 90,000; Full time

Job summary

A dynamic technology company in Wayzata is seeking an individual with 5-8 years of experience in a GMP laboratory to write and revise standard operating procedures. The candidate will collaborate with cross-functional teams, manage project timelines, and utilize tools like Veeva EDMS and SAP. Strong technical writing skills and the ability to influence without authority are key to success in this role, alongside a detail-oriented approach to document management.

Qualifications

• 5-8 years in a GMP lab environment with SOP writing experience.
• Experience with Veeva EDMS or similar document management systems.
• Excellent technical writing and detail orientation.

Responsibilities

• Write and revise SOPs for laboratory operations.
• Interview subject matter experts for actionable instructions.
• Maintain procedure lifecycle through review and approval.

Skills

Technical writing

Attention to detail

Cross-functional communication

Document management

Time management

Tools

Veeva EDMS

SAP

Microsoft Word

SharePoint

Microsoft Outlook

Job description

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.