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Manufacturing Qms Specialist Jobs (NOW HIRING)

Rexa, Inc.

QMS Specialist

Middleborough, MA · On-site

$54K - $68K/yr

As we expand into our new headquarters and manufacturing facility at 200 Canopy Drive in ... The ISO 9001 QMS Specialist helps keep our Quality Management System organized, current, and audit ...

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 ... Evaluate QMS effectiveness, manufacturing process controls, and adherence to IATF quality standards

SAB

Quality Systems Specialist

Sioux Falls, SD · Remote

$80K - $100K/yr

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

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How much do manufacturing qms specialist jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for manufacturing qms specialist in the United States is $28.04, according to ZipRecruiter salary data. Most workers in this role earn between $18.51 and $36.30 per hour, depending on experience, location, and employer.

What does a Manufacturing QMS Specialist do?

A Manufacturing QMS (Quality Management System) Specialist is responsible for developing, implementing, and maintaining quality management systems within a manufacturing environment. They ensure that products meet regulatory and company standards by conducting audits, coordinating corrective actions, and facilitating continuous improvement initiatives. Additionally, they train staff on quality procedures and help prepare documentation for compliance with industry regulations such as ISO 9001 or FDA requirements.

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

To thrive as a Manufacturing QMS Specialist, you need expertise in quality management systems, regulatory compliance, and process improvement, typically supported by a relevant degree and experience in manufacturing environments. Familiarity with ISO 9001 standards, audit management software, and quality control tools is essential, and certifications such as CQE or Six Sigma are often preferred. Strong attention to detail, analytical thinking, and effective communication skills help you identify issues and work collaboratively to resolve them. These competencies ensure robust quality processes, regulatory adherence, and consistent product excellence in manufacturing operations.

What are some common challenges faced by Manufacturing QMS Specialists when implementing new quality processes?

Manufacturing QMS Specialists often encounter challenges such as resistance to change from staff, integrating new processes with existing systems, and ensuring consistent compliance across all departments. Balancing production deadlines while maintaining stringent quality standards can also be demanding. Effective communication and continuous training are key to overcoming these obstacles and fostering a culture focused on quality improvement.

What is the difference between Manufacturing Qms Specialist vs Quality Assurance Technician?

AspectManufacturing Qms SpecialistQuality Assurance Technician
CertificationsISO 9001 Lead Auditor, CQEISO 9001 Internal Auditor, CQTA
Work EnvironmentManufacturing plants, quality departmentsProduction lines, inspection areas
Employer UsageManufacturers, quality management teamsQuality control labs, production facilities

The Manufacturing Qms Specialist focuses on developing, maintaining, and auditing quality management systems, ensuring compliance with standards like ISO 9001. The Quality Assurance Technician primarily conducts inspections and tests to verify product quality. While both roles support quality, the Qms Specialist has a broader responsibility for system compliance, whereas the Technician emphasizes product inspection and testing.

What is manufacturing QMS in the manufacturing industry?

A manufacturing QMS (Quality Management System) is a structured set of policies, processes, and procedures used by manufacturing companies to ensure product quality, compliance with standards, and continuous improvement. It typically involves documentation, audits, and tools like ISO 9001 to monitor and control quality throughout the production process.
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Manufacturing Qms Specialist jobs near you
Infographic showing various Manufacturing Qms Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 12% Part Time, and 2% Contract. Highlights an 79% Physical, 2% Hybrid, and 19% Remote job distribution, with an average salary of $58,318 per year, or $28 per hour.

Manufacturing QMS Specialist

Kashiv BioSciences, LLC

Chicago, IL • On-site

Full-time

Medical, Dental, Vision, Retirement

Re-posted 16 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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