Quality Assurance Compliance Specialist

Ameri-partners; North Carolina; On-site; USD 70,000 - 95,000; Full time

Job summary

Ameri Partners in the United States seeks a QA Compliance Associate to support deviation investigations, RCA, CAPA, and quality compliance activities in an FDA-regulated pharmaceutical environment.

This role collaborates with Manufacturing, QA, and QC teams, provides guidance to QA staff, and supports audits and change controls.

Qualifications

• Experience in deviations, CAPA, RCA, QMS, and technical writing.
• Experience with manufacturing processes, QA operations, and QC analysis.
• Proficiency in Microsoft Word and Excel.
• Aseptic pharmaceutical manufacturing experience.
• Knowledge of cGMP requirements.
• Previous QA leadership or supervisory experience.

Responsibilities

• Review and manage deviations, CAPAs, investigations, and vendor complaints.
• Perform Root Cause Analysis (RCA) and evaluate product quality impact.
• Prepare investigation reports and lot disposition assessments.
• Track corrective actions and maintain accurate QMS documentation.
• Support change controls, quality metrics, and regulatory audits.
• Collaborate with Manufacturing, QA, and QC teams to resolve quality issues.
• Provide technical guidance and mentoring to QA team members.
• Support investigation training and QA supervisory activities as needed.

Skills

Deviations management

CAPA

RCA

QMS

Technical writing

Tools

Microsoft Word

Microsoft Excel

Job description

Ameri Partners is seeking a QA Compliance Associate to support deviation investigations, Root Cause Analysis (RCA), CAPA, and quality compliance activities in an FDA-regulated pharmaceutical environment.

Key Responsibilities

• Review and manage deviations, CAPAs, investigations, and vendor complaints.
• Perform Root Cause Analysis (RCA) and evaluate product quality impact.
• Prepare investigation reports and lot disposition assessments.
• Track corrective actions and maintain accurate QMS documentation.
• Support change controls, quality metrics, and regulatory audits.
• Collaborate with Manufacturing, QA, and QC teams to resolve quality issues.
• Provide technical guidance and mentoring to QA team members.
• Support investigation training and QA supervisory activities as needed.

Required Qualifications

• Pharmaceutical or FDA-regulated industry experience.
• Strong knowledge of deviations, CAPA, RCA, QMS, and technical writing.
• Experience with manufacturing processes, QA operations, and QC analysis.
• Proficiency in Microsoft Word and Excel.
• Aseptic pharmaceutical manufacturing experience.
• Knowledge of cGMP requirements.
• Previous QA leadership or supervisory experience.