Quality Assurance Associate - Compliance & Audits

ClinLab Solutions Group; New Jersey; On-site; USD 65,000 - 90,000; Full time

Job summary

ClinLab Solutions Group is seeking a QA Associate to manage market complaints, oversee quality assurance and control activities, and support compliance and continuous improvement across production and warehouse facilities.

The role involves investigating complaints, developing training on SOPs and testing protocols, inspecting records for regulatory compliance, and assisting with audits, product release, and environmental monitoring programs across multiple county locations.

Qualifications

• Bachelor's degree in a science-related field
• 2–5 years of QA experience in FDA-regulated industries
• Proficiency with MS Office
• Strong organizational and communication skills
• Ability to work across multiple locations

Responsibilities

• Investigate, document, and coordinate responses to market complaints, preparing detailed reports and communicating with relevant stakeholders.
• Develop, revise, and deliver training on Standard Operating Procedures, testing protocols, and specifications, while maintaining accurate training records.
• Inspect production and warehousing procedures, logbooks, and records to ensure regulatory compliance and operational efficiency.
• Assist in internal and external audits, product release activities, and review of manufacturing records for accuracy and completeness.
• Monitor facility environments for microbial contaminants, oversee equipment cleaning and verification, and maintain trending data for environmental monitoring.
• Coordinate the sending of samples to third-party laboratories and manage retained samples and related documentation.
• Support the handling and disposal of product returns, participate in cleaning/method validation studies, and assist with filing of QA/QC documents.
• Identify opportunities for process improvement and perform additional duties as assigned by quality management, with responsibilities split between multiple locations within the county.

Skills

Microsoft Office

Attention to detail

Communication

Problem solving

Multi-tasking

Education

Bachelor's degree in a science-related field

Job description

ClinLab Solutions Group is seeking a QA Associate to manage market complaints, oversee quality assurance and control activities, and support compliance and continuous improvement across production and warehouse facilities.

The role involves investigating complaints, developing training on SOPs and testing protocols, inspecting records for regulatory compliance, and assisting with audits, product release, and environmental monitoring programs across multiple county locations.