Senior QA Deviation Lead - CAPA, Root Cause & FDA Remediation

United Pharma; North Carolina; On-site; USD 100,000 - 130,000; Full time

Job summary

United Pharma in North Carolina is seeking an experienced QA Investigator Lead to manage deviations across aseptic production. You will collect data, lead root cause analysis, and determine CAPAs to prevent recurrence while ensuring FDA compliance.

The role requires a Bachelor's degree, expert knowledge of deviation resolution, strong written reports, and effective cross‑functional collaboration to meet KPIs and project timelines.

Qualifications

• Bachelor’s degree from an accredited college/university.
• Fluent written and verbal English; other languages are a plus.
• +10 years of experience in Aseptic Processing with deviation investigation and report writing.
• Expert level understanding of deviation resolution and CAPA management.
• Experience with remediation plans for the US FDA.
• Knowledge of QA tasks including PQR, auditing, change control, complaints, OOS, batch records.

Responsibilities

• Conducts Minor / Major / Critical Deviation investigations and documents investigations.
• Collects raw data and information needed to process investigations.
• Leads Root Cause Analysis to identify probable causes, determine product impact, and assign CAPAs with responsibilities and due dates.
• Performs trending to identify and report adverse trends requiring action.
• Writes investigation reports and completes investigations within specified timeframes.
• Develops corrective and preventative actions and follows up to ensure effectiveness.
• Manages client communications to obtain timely approval of investigation reports and reports progress to Project Leader.

Skills

Root cause analysis

CAPA management

Investigation writing

Data collection

Trend analysis

Client communications

KPI focus

English communication

Education

Bachelor’s degree

Job description

United Pharma in North Carolina is seeking an experienced QA Investigator Lead to manage deviations across aseptic production. You will collect data, lead root cause analysis, and determine CAPAs to prevent recurrence while ensuring FDA compliance.

The role requires a Bachelor's degree, expert knowledge of deviation resolution, strong written reports, and effective cross‑functional collaboration to meet KPIs and project timelines.