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Mastercontrol Qms Jobs in Wisconsin (NOW HIRING)

Automated Systems, Inc.

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GMP Technical Writer

Kenosha, WI · On-site

$60 - $75/hr

  • Medical

  • Dental

  • PTO

... MasterControl through review, approval, and effective date cycles Draft and revise SOPs, Work ... QMS frameworks Exposure to legacy site remediation or quality system transition projects ...

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Mastercontrol Qms information

What is MasterControl Qms?

MasterControl QMS (Quality Management System) is a cloud-based software platform designed to help organizations automate and manage their quality processes. It streamlines document control, training management, audit management, CAPA (Corrective and Preventive Actions), and other quality-related activities. The system is widely used in regulated industries such as life sciences, pharmaceuticals, and manufacturing to ensure compliance with standards like FDA, ISO, and others. MasterControl QMS helps companies improve efficiency, reduce errors, and maintain regulatory compliance through centralized and automated quality management.

What skills and qualifications are needed to work with MasterControl Qms?

To excel as a MasterControl QMS Specialist, you need a solid understanding of quality management principles, document control processes, and regulations such as FDA or ISO standards, typically supported by experience in quality assurance or a related field. Proficiency with the MasterControl Quality Management System software, electronic document management tools, and possibly certifications like Six Sigma or ASQ are highly valued. Strong attention to detail, problem-solving abilities, and effective communication skills help ensure quality processes are maintained and improved. These skills are vital for maintaining compliance, streamlining workflows, and supporting continuous improvement in regulated industries.

What are common challenges when working with MasterControl Qms, and how can they be addressed?

Professionals working with MasterControl QMS often encounter challenges such as managing system configurations to fit evolving compliance requirements, training end-users effectively, and ensuring smooth integration with existing business processes. Successfully addressing these challenges involves staying updated on regulatory changes, investing time in thorough user training, and collaborating closely with IT and quality assurance teams. Regular communication and proactive troubleshooting are key to maximizing the system's efficiency and maintaining compliance.

What is the difference between Mastercontrol Qms vs Quality Assurance Specialist?

AspectMastercontrol QmsQuality Assurance Specialist
CertificationsISO 9001, internal audits, compliance trainingISO 9001, Six Sigma, GMP certifications
Work EnvironmentQuality management systems, document control, compliance teamsLaboratories, manufacturing, production facilities
Employer & IndustryRegulated industries like healthcare, pharma, medical devicesManufacturing, pharmaceuticals, biotech

Mastercontrol Qms professionals focus on managing quality management systems, documentation, and compliance processes. Quality Assurance Specialists perform testing, inspections, and ensure product quality. While both roles support quality objectives, Mastercontrol Qms roles are more system and process-oriented, whereas Quality Assurance Specialists are more hands-on with product testing and validation.

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For Mastercontrol Qms jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Mastercontrol Qms jobs in Wisconsin look for?

The top searched job categories for Mastercontrol Qms jobs in Wisconsin are:

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Cities in Wisconsin with the most Mastercontrol Qms job openings:

Mastercontrol Qms jobs near you
Infographic showing various Mastercontrol Qms job openings in Wisconsin as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

GMP Technical Writer

Automated Systems, Inc.

Kenosha, WI • On-site

$60 - $75/hr

Contractor

Medical, Dental, PTO

Posted 4 days ago

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Job description

GMP Technical Writer

Contract: 12 - 18 months duration

Location: Kenosha County, WI. – onsite

Automated Systems, Inc. is seeking a GMP Technical Writer with engineering documentation experience to support backlog closure across Deviations (DEVs), CAPAs, and Change Controls at one of our clients pharmaceutical manufacturing sites located in the Kenosha County Area, WI. This is a cross-discipline support role embedded with the Engineering team, providing structured writing, document control, and quality system support to Automation, Utilities, and Facilities engineers who need bandwidth relief to focus on active project execution.

Key Responsibilities:

 

Author and finalize GMP documents including Deviation reports, CAPA records, Change Control packages, and engineering work orders

Interface with Automation, Utilities, and Facilities engineers to gather technical content and translate to GMP-compliant documentation

Manage document routing in Veeva QualityDocs and/or MasterControl through review, approval, and effective date cycles

Draft and revise SOPs, Work Instructions, and engineering procedures to meet LQS/GQS requirements

Maintain documentation trackers (Smartsheet, Excel) for open items, approval queues, and closure timelines

Support change control classification and rationale documentation under applicable site SOPs

Coordinate cross-discipline document interdependencies to prevent routing bottlenecks


Required Qualifications:

 

4+ years of GMP technical writing experience in pharmaceutical, biotech, or medical device manufacturing

Demonstrated experience authoring Deviation reports, CAPA records, and Change Control pack

ages

Proficiency with electronic quality management systems — Veeva QualityDocs, MasterControl, or Track Wise

Strong understanding of GMP documentation principles (data integrity, version control, review/approval workflows)

Excellent written communication and ability to distill complex engineering information into compliant, auditable documentation

Preferred Qualifications:

Experience supporting engineering-side documentation (automation, utilities, or facilities)

Familiarity with quality systems or equivalent top-tier pharma QMS frameworks

Exposure to legacy site remediation or quality system transition projects

Proficiency in Smartsheet or equivalent project tracking platforms

Company Description

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.