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Mastercontrol Qms Jobs (NOW HIRING)

MasterControl

Account Executive - Qx

Salt Lake City, UT · On-site +1

Summary MasterControl is looking for a motivated Account Executive to join our Quality Excellence ... Prior experience with or working knowledge of Quality Management Systems (QMS) or electronic QMS ...

MasterControl

Account Executive - Qx

Salt Lake City, UT · On-site +1

Summary MasterControl is looking for a motivated Account Executive to join our Quality Excellence ... Prior experience with or working knowledge of Quality Management Systems (QMS) or electronic QMS ...

Bachem

QMS Process Engineer

Vista, CA · On-site

$82K - $114K/yr

A brief overview The Quality Management Systems (QMS) Process Engineer / Sr. Process Engineer plays ... Veeva MasterControl, LIMS, SAP etc.) * Ability to manage projects, organize and work in a fast ...

Bachem

QMS Process Engineer

Vista, CA · On-site

$82K - $114K/yr

A brief overview The Quality Management Systems (QMS) Process Engineer / Sr. Process Engineer plays ... Veeva MasterControl, LIMS, SAP etc.) * Ability to manage projects, organize and work in a fast ...

SNAP Diagnostics

Quality Systems Engineer

Anderson, SC · On-site

... QMS) to ensure compliance with ISO standards, regulatory requirements, and internal policies. This role manages document control systems (MasterControl and SharePoint), supports audits, drives ...

NIRA, Inc.

QMS Administrator/Developer

Hyattsville, MD · On-site

$100K/yr

This role will support the transition from the current MasterControl document and quality management system to a new enterprise platform, including system implementation, workflow configuration, and ...

NIRA, Inc.

QMS Administrator/Developer

Hyattsville, MD · On-site

$100K/yr

This role will support the transition from the current MasterControl document and quality management system to a new enterprise platform, including system implementation, workflow configuration, and ...

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Mastercontrol Qms information

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.

What are some common challenges faced by professionals 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 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 are the key skills and qualifications needed to thrive as a MasterControl QMS Specialist, and why are they important?

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.
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Mastercontrol Qms jobs near you
Infographic showing various Mastercontrol Qms job openings in the United States as of June 2026, with employment types broken down into 83% Full Time, and 17% Contract. Highlights an 100% In-person job distribution.

QMS & SAP Validation Analyst (Contract)

Kashiv BioSciences, LLC

Piscataway, NJ

$65 - $75/hr

Other

Posted 18 days ago

Job description

Description


Position Type: Contractor / Consultant - FTC (6-9 Months with possible extension)

Location: Piscataway, NJ (onsite - physical presence required) - OR - Chicago, IL (onsite - physical presence required)

Reports To: Sr. Director of IT

Rate: $65-$75/hour, not overtime eligible

Work Authorization: Must be authorized to work in the U.S. without sponsorship, now or in the future


Position Summary


We are seeking a Validation Analyst to support validation of our Quality Management System (MasterControl) and SAP implementation (QM, Materials Management, Production modules). This role works under the direction of a senior validation lead and partners with Quality, IT, and business functions to deliver validation artifacts in compliance with 21 CFR Part 11, GxP, and EMA expectations.


Essential Duties & Responsibilities

  • Support validation of MasterControl QMS - authoring and executing IQ/OQ/PQ protocols, traceability matrices, and validation summary reports
  • Support  SAP implementation and validation activities across QM, MM, and PP modules, including test script authoring and execution under senior oversight
  • Contribute to risk assessments, data integrity assessments, and change control documentation
  • Liaise with QA, IT, business process owners, and external SAP implementation partners
  • Support periodic review and maintenance of validated state for assigned systems
  • Assist in audit and inspection readiness for MasterControl and SAP

Requirements

 Position Requirements and Qualifications

  • Bachelor's degree in Life Sciences, Engineering, IT, or a lab-based role in life      sciences with 3+ years of relevant experience; OR Master's degree with 1-2 years of relevant experience
  • Prior exposure to CSV activities in a GxP-regulated environment
  • Working understanding of 21 CFR Part 11, EU Annex 11, and EMA guidance
  • Experience authoring or executing validation protocols

Experience:  

  • Exposure to MasterControl QMS (validation, administration, or end-user)
  • Exposure to SAP (any module, ideally QM, MM, or PP) in a GxP environment
  • Familiarity with GAMP 5 principles
  • Experience with ALCOA+ data integrity principles
  • Prior experience supporting enterprise system implementations in pharma, biotech, or medical device

Specialized Knowledge and Skills:  

  • Familiarity with GAMP 5 principles and risk-based validation
  • Exposure to Caliber LIMS
  • Exposure to SAP (QM, MM, PP) in a GxP context
  • Prior experience and acting as a liaison across IT, Quality, Lab, and ERP (SAP Preferred) and related systems.

Work Environment & Physical Demands: 

  • This is an on-site position at our Piscataway, NJ location - OR - Chicago, IL location 
  • Must be able to work extended hours or weekend hours, as may be required.

Noise: 

  • No extraordinary noise levels.

Standing/Lifting: 

  • Very unlikely, but can be able to lift at least 20 lbs.

Visual: 

  • No extraordinary requirements.

Stress: 

  • High-paced demanding environment to meet ambitious project goals.

Travel: 

  • Moderate domestic travel may be required. 

Apply