HORIZON TOOL, INC.
An organized and motivated Quality Coordinator that supports our Quality Assurance team in our fast-paced cosmetic and industrial chemical industry. This role is for individuals with foundational quality experience and familiarity with ISO documentation who are looking to grow their skills in a regulated, consumer-focused manufacturing environment. They will collaborate across teams to help maintain the integrity of our quality systems and ensure regulatory readiness. They will also assist in maintaining ISO-compliant systems, ensuring product and in-process quality, and supporting regulatory documentation needs.
Qualification Requirements
Minimum Qualifications
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the position. All employees may have other duties assigned at any time.
Qualification Requirements
- Experience supporting audits (FDA, ISO, or customer)
- Prior experience in a chemical manufacturing environment or knowledge of batch process operations
- Understanding Batch record development, o other chemical compliance environments
- Experience with QMS systems or digital documentation systems
- Exposure to root Cause Analysis, CAPA, or Lean/Six Sigma methodologies
Minimum Qualifications
- Bachelor's degree in chemistry, Chemical Engineering, Quality Assurance, or a related field.
- 1-2 years of experience in a quality or regulatory support role in the cosmetic, or chemical manufacturing industry
- Familiarity with ISO 9001, ISO 22716, and document control best practices
- Understanding good manufacturing practices (GMP) and basic regulatory documentation (SDS, CoA, etc.)
- Strong organizational skills, attention to detail, and ability to work with cross-functional teams
- Proficient in Microsoft Office and/or QMS/document control systems
- Quality management systems (QMS)
- CAPA (Corrective and Preventive Actions)
- Deviation & change control
- Batch record review
- Understanding of regulatory guidelines (FDA, Cosmetics Regulation, etc.)
- Proficient in documentation and record-keeping for audits and compliance
- Assist in managing the Quality Management System (QMS) in compliance with ISO 9001, ISO 22716 (GMP for cosmetics), and internal quality standards
- Create, revise, and control quality documentation, including SOPs, batch records, and change control forms
- Support internal audits, document audits, and gap assessments related to GMP and ISO standards
- Track and assist in resolving non-conformances, deviations, customer complaints, and CAPAs
- Coordinate document control processes, including version management and proper archival of controlled records
- Help prepare for third-party audits, customer audits, and regulatory inspections
- Liaise with Production, R&D, Regulatory Affairs, and QC to support new product introduction and continuous quality improvement
- Monitor compliance with cGMP, labeling, traceability, and packaging requirements in line with FDA regulations
- Assist in generating quality metrics and compliance reports for management review.
- Standing, sitting, stooping, kneeling, crouching, reaching for extended periods of time
- Hearing in a noisy environment
- Color differentiation
- Depth perception
- Tactile discernment
- Handling packaging
- Must be able to lift up to 25 pounds frequently
- Exposure to a Production area, chemical mixing, gowning area, laboratory environment, filling and packaging lines heat or cold, exposure to chemicals, wet and/or humid conditions, proximity to moving mechanical parts.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the position. All employees may have other duties assigned at any time.