Sr. QA Deviation Specialist

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

• Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately
• Collects raw data and information needed to process the investigation
• Leads Root Cause Analysis to identify the most probable root cause, determine product impact, and assign appropriate CAPAs with responsibilities and due dates
• Performs trending to identify and report adverse trends that may require further action
• Writes the investigation report and completes investigations within the specified time-frames
• Develops corrective and preventative actions to prevent problem recurrence and establishes an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective
• Manage client communications efficiently and effectively, to obtain timely approval of investigation reports
• Reports work progress and performance metrics to Project Leader on a daily and weekly basis

Requirements

• Bachelor’s degree from an accredited college/university
• Appropriate written and verbal communication skills in English and in any other relevant language(s)
• +10 years of experience in Aseptic Processing facilities, with proven expertise in production deviation investigation and report writing
• Expert level understanding of deviation resolution for manufacturing processes and CAPA management
• Previous experience with remediation plans for the US FDA
• Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management)
• Collaborative team player with a strong focus on achieving KPIs and project goals while effectively navigating conflict and driving win-win resolutions