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Mastercontrol Qms Jobs in Indiana (NOW HIRING)

INCOG

Senior Audit Specialist

Fishers, IN

... QMS platforms (e.g., Veeva, TrackWise, MasterControl) Experience with combination products and knowledge of ISO 13485. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built ...

EHOB INC

Quality Assurance Engineer

Indianapolis, IN

Coordinate the activities for Quality Management System (QMS) review and present the supporting ... Experience with MasterControl eQMS is a plus. * Proficiency in root cause analysis and corrective ...

INCOG

QA Supervisor, IDAP

Fishers, IN · On-site

Familiarity with sterile injectable drug product manufacturing, including aseptic fill-finish operations Experience with electronic QMS platforms (e.g., TrackWise, Veeva, MasterControl) and document ...

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Mastercontrol Qms information

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.

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 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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Mastercontrol Qms jobs near you
Infographic showing various Mastercontrol Qms job openings in Indiana as of May 2026, with employment types broken down into 1% Internship, 22% Full Time, 8% Part Time, 2% Temporary, 58% Contract, and 9% Nights. Highlights an 100% Physical job distribution.
Global GxP Quality Project Manager - Pharmaceutical (Hybrid - Indianapolis, IN) Contract

Global GxP Quality Project Manager - Pharmaceutical (Hybrid - Indianapolis, IN) Contract

Pharmavise

Indianapolis, IN • On-site

Contractor

Posted 10 days ago

Job description

Job Description
Our Fortune 500 global Pharmaceutical client is seeking an experienced Global GxP Quality Project Manager.
Job Summary:
The Global GxP Project Manager will support enterprise-level Global Quality Transformation and Technology initiatives. This role operates within Global Quality leadership and supports strategic transformation efforts across Quality Culture, Quality Maturity Systems, and global QMS modernization. The scope is global and not site-specific. The organization requires a structured, transformation-driven PM who understands regulated environments, Lean deployment, and digital Quality enablement.
Key Responsibilities:
  • Lead global GxP Quality transformation programs across multiple sites and functions

  • Drive QMS harmonization and enterprise process standardization initiatives

  • Support inspection readiness modernization and alignment with FDA expectations

  • Optimize CAPA and Deviation lifecycle processes through structured improvement efforts

  • Deploy Lean methodologies within Quality functions to improve efficiency and reduce waste

  • Support implementation or enhancement of digital Quality systems (Veeva QMS, TrackWise, MasterControl)

  • Lead initiatives involving digital logbooks, eBR, MES integration, and Quality data analytics

  • Enable development of Quality Maturity metrics, dashboards, and executive reporting tools

  • Drive automation and AI-enabled improvements in Quality workflows where applicable

  • Provide structured governance, PMO alignment, and milestone tracking

  • Manage cross-functional stakeholder engagement across Quality, Regulatory, Manufacturing, and Technology

  • Identify and mitigate program risks in a global, regulated environment

  • Prepare executive-level updates and KPI dashboards for senior leadership

Required Qualifications:
  • 8-10+ years of experience in pharmaceutical and/or medical device industries

  • Bachelor's degree in a scientific, life sciences, or health-related field

  • Strong GxP knowledge (GMP, FDA Quality Systems Regulations)

  • Experience leading enterprise-level Quality or QMS transformation initiatives

  • Experience supporting global or multi-site programs

  • Demonstrated Lean deployment or process improvement experience

  • Strong stakeholder management and executive communication skills

  • Ability to work onsite in Indianapolis, IN

Preferred Qualifications:
  • PMP certification

  • Lean certification (Lean Six Sigma Green Belt or Black Belt preferred)

  • Experience with Veeva QMS, TrackWise, or MasterControl

  • Drug and medical device experience

  • Experience supporting inspection readiness or regulatory scrutiny

Other Details:
Schedule: Full Time

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