Onsite Quality Auditor – Documentation & Compliance

Connexion Systems & Engineering Inc.; Chicago (IL); On-site; USD 55,000 - 69,000; Full time

Job summary

Connexion Systems & Engineering is seeking a detail-oriented Quality Auditor to support a regulated manufacturing environment by ensuring documentation accuracy, compliance, and quality throughout production.

The role involves auditing batch records, production documentation, labels, and electronic quality records, with strict adherence to FDA Good Tissue Practices (21 CFR Part 1271). Onsite in Chicago with standard business hours, Monday–Friday.

Qualifications

• Experience in QA, QC, or documentation auditing within a regulated industry.
• Strong attention to detail with the ability to identify documentation discrepancies.
• Experience auditing batch records, production records, or similar controlled documentation preferred.
• Proficient with Microsoft Excel, Word, and Outlook.

Responsibilities

• Perform quality reviews of documentation related to product recovery, processing, labeling, storage, and distribution.
• Audit batch records, production documentation, and data entry for completeness and accuracy.
• Review labels and upload documentation into electronic quality systems.
• Audit laboratory culture reports and maintain organized documentation files.
• Ensure compliance with FDA Good Tissue Practices (21 CFR Part 1271), industry standards, and internal quality procedures.
• Maintain accurate records while adhering to company documentation requirements.
• Collaborate with cross-functional teams to support quality and compliance initiatives.
• Perform additional quality-related duties as assigned.

Skills

QA experience

QC experience

Documentation auditing

Attention to detail

Communication

Independence

Tools

MS Excel

MS Word

MS Outlook

Job description

Connexion Systems & Engineering is seeking a detail-oriented Quality Auditor to support a regulated manufacturing environment by ensuring documentation accuracy, compliance, and quality throughout production.

The role involves auditing batch records, production documentation, labels, and electronic quality records, with strict adherence to FDA Good Tissue Practices (21 CFR Part 1271). Onsite in Chicago with standard business hours, Monday–Friday.