Quality Systems Associate

Jobtailor; United States; On-site; USD 40,000 - 75,000; Full time

Job summary

Jobtailor in the United States seeks a QA/QC training-focused professional to ensure compliance with FDA regulations and cGMP standards. You will support quality systems, review equipment QC data, and conduct root-cause analyses for deviations and complaints.

The role requires a high school diploma or GED, strong numerical skills, and proficiency with computers, with the ability to work flexible hours to meet business needs.

Qualifications

• High school diploma or GED required.
• Understanding of FDA regulations.
• Knowledge of cGMP and quality systems.
• Developing interpersonal, organizational and problem-solving skills.
• Strong integrity and commitment to quality and compliance.
• Good mathematical ability.
• Legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.

Responsibilities

• Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol.
• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints.
• Inspect and release incoming supplies.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed.
• Create, maintain, and audit training records and files to ensure compliance.
• Conduct employee training observations.
• Review lookback information and documentation.
• Conduct training to address donor center corrective and preventive measures.

Skills

FDA regulations understanding

cGMP knowledge

Quality systems understanding

Interpersonal communication

Organizational skills

Problem-solving

Data entry / computer proficiency

Education

High school diploma or GED

Tools

Microsoft Office

Job description

Responsibilities

• Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol
• Complete weekly review of equipment QC and maintenance records
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints
• Inspect and release incoming supplies
• Perform documentation review for unsuitable test results
• Assist the Quality Systems Manager to ensure cGMP regulation, SOPs and regulatory requirements are followed
• Create, maintain, and audit training records and files to ensure compliance
• Conduct employee training observations
• Review lookback information and documentation
• Conduct training to address donor center corrective and preventive measures

Requirements

• High school diploma or GED
• Ability to understand FDA regulations
• Basic understanding of cGMP and quality systems
• Developing command of interpersonal communication, organizational and problem‑solving skills
• Strong integrity and commitment to quality and compliance
• Good knowledge of mathematics
• Legible handwriting
• Proficiency with computers
• Ability to work flexible scheduling to meet business needs