Technical Writer

Jobtailor; Pleasant Prairie (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Jobtailor in Wisconsin seeks a Compliance Writer to support cGMP operations. You will write deviations, action plans, SOPs, and ECRs, and assist with audit responses.

You will collaborate with process experts and production staff, manage multiple investigations, and ensure investigations meet regulatory requirements. On-site presence is required during inspections.

Qualifications

• Writing deviations, action plans, trend reports, and engineering change requests (ECRs).
• Assisting with the writing and revision of standard operating procedures (SOPs).
• Assisting with audit response development and regulatory compliance.

Responsibilities

• Taking direction from the Manager of Compliance regarding related activities.
• Managing multiple deviation investigations simultaneously.
• Ensuring investigations comply with cGMP regulations.
• Collaborating with process experts and production personnel to solve problems.

Skills

SOP writing

Deviation investigation

Regulatory compliance

Report writing

Cross-functional collaboration

Education

Bachelor of Science degree recommended

Job description

Responsibilities

• Writing deviations, action plans, trend reports, and engineer change requests (ECR’s)
• Assisting with the writing and revision of standard operating procedures
• Assisting with audit response development
• Taking direction from the Manager of Compliance regarding any related activities as needed
• Managing multiple deviation investigations simultaneously
• Ensuring investigations comply with cGMP regulations
• Collaborating with process experts and production personnel to solve problems
• Writing and revising SOP’s based upon input from operations or other subject matter experts
• Creating trend reports necessary to meet compliance obligations and KPI’s
• On-site presence before and during inspections to support the operations team

Requirements

• Bachelor of Science degree recommended
• Requires advanced critical thinking skills and expert writing skills
• At least three years’ experience in a GMP environment writing standard operating procedures and/or deviations/action plans
• Must be familiar with regulatory (FDA) requirements
• Good organizational, communication, and interpersonal skills are required