Quality Engineer: GMP/FDA Compliance & Process Validation

Alltrista Plastics LLC; Greenville (SC); On-site; USD 50,000 - 70,000; Full time

Job summary

A manufacturing company in South Carolina is seeking a Quality Assurance Specialist who will ensure compliance with GMP, ISO, and FDA standards. The ideal candidate has 3-5 years of experience in inspections within a high-volume production environment, and is knowledgeable in quality management systems. This role involves auditing quality systems, developing validation procedures, and coordinating inspections, alongside the ability to utilize various quality tools and technologies.

Qualifications

• Three to five years experience in inspection in a high-volume production environment.
• Experience with control charts, capability studies, and statistical tools.
• Knowledge of ISO 9001/QMS and ISO 13485.

Responsibilities

• Audits quality systems for GMP, ISO, and FDA compliance.
• Coordinates and writes inspection plans for molds.
• Develops product and equipment validation procedures.

Skills

GMP

ISO compliance

FDA regulations

SPC

quality auditing

blueprint reading

root cause analysis

Education

Associate or bachelor's degree

Tools

SPC software

LAN/CIM

statistical software

graphical spreadsheets

word processing software

Job description

A manufacturing company in South Carolina is seeking a Quality Assurance Specialist who will ensure compliance with GMP, ISO, and FDA standards. The ideal candidate has 3-5 years of experience in inspections within a high-volume production environment, and is knowledgeable in quality management systems. This role involves auditing quality systems, developing validation procedures, and coordinating inspections, alongside the ability to utilize various quality tools and technologies.