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Qms Specialist Jobs (NOW HIRING)

Highridge Medical

QMS Specialist

Westminster, CO · On-site

QMS Specialist Principal Duties and Responsibilities Material Documentation Support and Testing • Implement and maintain the CAPA program including software solutions. • Duties include, but are ...

Highridge Medical

QMS Specialist

Westminster, CO · On-site

QMS Specialist Principal Duties and Responsibilities Material Documentation Support and Testing Implement and maintain the CAPA program including software solutions. Duties include, but are not ...

TE Connectivity

QMS SPECIALIST III

Tullahoma, TN · On-site

$92K - $116K/yr

QMS SPECIALIST III Posting Start Date: 4/23/26 At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected ...

SAB

Quality Systems Specialist

Sioux Falls, SD · Remote

$80K - $100K/yr

The Quality Management System (QMS) Specialist is responsible for the administration, maintenance, and continuous improvement of the company's Quality Management System to ensure compliance with ...

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Qms Specialist information

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$34.5K

$54.5K

$73K

How much do qms specialist jobs pay per year?

As of Aug 13, 2026, the average yearly pay for qms specialist in the United States is $54,475.00, according to ZipRecruiter salary data. Most workers in this role earn between $37,500.00 and $65,000.00 per year, depending on experience, location, and employer.

What does a QMS Specialist do?

A QMS (Quality Management System) Specialist is responsible for developing, implementing, and maintaining quality management systems within an organization. They ensure compliance with industry standards such as ISO 9001 and work to improve processes, documentation, and training related to quality assurance. QMS Specialists also conduct audits, analyze data to identify areas for improvement, and collaborate with different departments to ensure that quality standards are consistently met. Their role is vital for organizations that need to meet regulatory requirements and deliver high-quality products or services.

What are the key skills and qualifications needed to thrive as a QMS Specialist?

To thrive as a QMS Specialist, you need a solid understanding of quality management principles, regulatory standards (such as ISO 9001), and a background in quality assurance or related fields. Familiarity with quality management systems software, audit tools, and relevant certifications like ISO Lead Auditor are highly beneficial. Exceptional attention to detail, analytical thinking, and strong communication skills help you effectively implement and monitor quality processes. These skills ensure compliance, continuous improvement, and overall product or service excellence within an organization.

What is the difference between Qms Specialist vs Quality Technician?

AspectQms SpecialistQuality Technician
CredentialsISO 9001 auditor certification, quality management trainingBasic quality assurance training, sometimes certifications like CQI or CQE
Work EnvironmentDeveloping and maintaining quality management systems, audits, process improvementInspecting products, testing, recording quality data
Employer & Industry UsageManufacturing, aerospace, automotive, regulated industriesManufacturing, electronics, consumer goods
Search & Comparison IntentFocus on quality system management rolesFocus on product inspection and testing roles

The Qms Specialist primarily manages and improves quality management systems, ensuring compliance with standards like ISO 9001. In contrast, a Quality Technician focuses on inspecting products, testing, and recording quality data. Both roles are essential in manufacturing environments but differ in scope and responsibilities.

What are some common challenges a QMS Specialist faces when implementing new quality management processes within an organization?

QMS Specialists often encounter challenges such as resistance to change from staff, aligning new processes with existing workflows, and ensuring compliance with industry regulations. Effective communication and training are critical to help team members understand the benefits of updated quality management systems. Additionally, QMS Specialists need to continuously monitor and adapt processes based on feedback and audit results to maintain high quality standards.
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Qms Specialist jobs near you
Infographic showing various Qms Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 13% Part Time, and 3% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $54,475 per year, or $26.2 per hour.

Manufacturing QMS Specialist

Kashiv BioSciences, LLC

Chicago, IL • On-site

Full-time

Medical, Dental, Vision, Retirement

Re-posted 10 days ago

Job description

Description

The Manufacturing QMS Specialist , is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC. This position is located in Chicago, IL. Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs etc. This position requires technical expertise in the upstream and downstream process of biologics (Cytokines, monoclonal antibodies manufacturing).


Essential Duties & Responsibilities

  • Will be responsible for supporting the manufacturing team with all kinds of documentation. 
  • Documentation includes reviewing executed batch records (both Upstream department and Downstream batch record). 
  • Will be responsible for filing change controls, Deviation, and CAPA for manufacturing department. 
  • For all critical / major investigation, will have to use investigation tools like 5Why or 6M method.
  • Attend daily meetings with both upstream and downstream process to get all the documentation requirements for the day.
  • Will meet weekly with QA to avoid any delay in the QMS closure.
  • Will author batch records, SOPs and associated forms / formats required for the manufacturing process.
  • Will be responsible for requesting / submitting all GMP documents to QA.
  • During critical campaign, will support manufacturing process (rotating shifts)
  • Wet lab work will not be more than 10 % of your time. 
  • Performs other functions as required or assigned.
  • Complies with all company policies and standards. 

Requirements

Education:

  • A Minimum BA or BS in Biological Sciences or related technical field is required. 
  • Minimum 5 years of experience in Biopharmaceuticals. 
  • Knowledge in USP and DSP process

Special Skills:

  • Ability to work with other team members and independently - good interpersonal skills.
  • Good communication skills: verbal and written, good computer and organization skills, detail oriented.
  • Basic computer skills, including knowledge of Word, Excel and spread sheet
  • Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
  • Knowledgeable in cleaning verification/validation. 

Work Environment & Physical Demands:

  • Noise: No extraordinary noise levels.
  • Standing/Lifting: No extraordinary requirements.
  • Visual: No extraordinary requirements.
  • Stress: High-paced demanding environment to meet ambitious project goals.
  • Travel: None


General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.


Supervisory Responsibility, if any: No


Benefits/Perks:

  • Medical
  • Dental
  • Vision
  • 401K
  • FSA 
  • HSA
  • Commuter/Transit Benefits
  • Student Loan Assistance Program
  • Monthly Cell Phone Allowance
  • Free Parking (Company Paid)
  • Conveniently located next to the Metra, Green and Red Line
  • One block east of the Chicago White Sox Stadium
  • < 10 minutes away from Downtown Chicago

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.


Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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