Technical Writer, Microbiology Quality Control

Medline Industries, Inc.; Mundelein (IL); On-site; USD 68,000 - 100,000; Full time

Job summary

An established industry player is seeking a meticulous Technical Writer to create and manage essential documentation for their operations. This role involves writing Standard Operating Procedures and coordinating investigations into non-conformances, ensuring clarity and compliance with regulatory standards. The ideal candidate will possess strong analytical skills and the ability to transform complex technical concepts into accessible language. Join a dynamic team that values diversity and offers growth opportunities within a global organization, all while contributing to the enhancement of quality processes in the medical and pharmaceutical fields.

Benefits

Health Insurance

Life and Disability Coverage

401(k)

Paid Time Off

Employee Assistance Program

Employee Resource Groups

Qualifications

• 2+ years of experience in a regulated field or 1 year with MS Excel and Word.
• Knowledge of FDA GMP compliant manufacturing is a plus.

Responsibilities

• Create and edit SOPs, deviations, and change control documents.
• Coordinate investigations and collaborate with subject matter experts.
• Analyze manufacturing process trends based on quality reports.

Skills

Technical Writing

Root Cause Analysis

Document Control

Communication Skills

Project Management

Education

Bachelor's Degree in a Relevant Field

Tools

Microsoft Excel

Microsoft Word

Adobe Acrobat Pro

Adobe InDesign

Adobe Photoshop

Adobe Illustrator

Microsoft Visio

Job description

Job Summary

Write Standard Operating Procedures (SOPs), change controls, deviations, non-conforming material reports, and training materials based on validated processes. Responsible for determining root cause, authoring, and implementing corrective actions associated with deviations and non-conforming material reports (NCMRs). Design, develop, and implement customized technical documents for use across various teams. Gather information about needs, objectives, functions, features, and requirements. Conduct work assignments of increasing complexity under moderate supervision with latitude for independent judgment. Transform technical and scientific concepts into simple language to ensure clarity for average readers.

Job Description

Responsibilities:

1. Responsible for creating, editing, and coordinating procedures, SOPs, deviations, non-conforming material reports, and change control documents. Coordinate deviation and non-conformance investigations. Collaborate with subject matter experts to identify root causes and corrective actions.
2. Identify documentation needs across maintenance, production, quality, and engineering teams.
3. Design and manage independent projects, providing regular updates to team members.
4. Interview personnel from production, maintenance, and engineering to understand product technologies and production methods. Observe activities to determine work instructions and training documentation needs.
5. Oversee document review processes, ensuring approval by relevant experts and regulatory personnel prior to finalization.
6. Use photographs, drawings, sketches, diagrams, and charts to illustrate technical or scientific concepts. Study drawings, specifications, and equipment to draft detailed procedures and reports.
7. Analyze manufacturing process trends based on quality reports such as deviations and NCMRs. Collaborate with teams to track information and create trend reports.
8. Organize and complete writing assignments adhering to standards of clarity, conciseness, style, and terminology. Edit and standardize material prepared by others.

Minimum Qualifications:

• At least two years of experience in Medical, Pharmaceutical, Manufacturing, or a regulated field, or at least one year of experience with Microsoft Excel and Word.
• Experience with Adobe Acrobat Pro.

Preferred Qualifications:

• Knowledge of FDA GMP compliant manufacturing is a plus.
• Experience with Adobe InDesign, Photoshop, Illustrator, and Microsoft Visio is a plus.
• Experience in training, teaching, or instructional design is a plus.

Medline Industries, LP, and its subsidiaries offer a competitive rewards package, continuing education, and growth opportunities within a global organization.

The anticipated salary range for this position is $68,640.00 - $99,320.00 annually. Actual salary varies based on location, education, experience, skills, and abilities. The role is eligible for bonuses and incentives. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefits include health insurance, life and disability coverage, 401(k), paid time off, and more for employees working 30+ hours per week. For less than 30 hours, benefits include 401(k), Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.

We are committed to diversity and inclusion, valuing the differences each individual brings. Learn more about our Diversity, Equity, and Inclusion initiatives here.

Medline Industries, LP is an equal opportunity employer, evaluating all applicants without regard to legally protected characteristics.