Sr. Deviation Investigator

United Pharma; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma in North Carolina seeks a senior QA professional to lead deviation investigations across minor, major and critical cases, ensuring timely and well-documented records. You will collect data, perform root cause analyses and assign CAPAs with clear responsibilities and due dates.

You will manage client communications, report progress to the Project Leader daily and weekly, and contribute to remediation plans for US FDA compliance.

Qualifications

• Bachelor’s degree from an accredited college/university
• Appropriate written and verbal communication skills in English and in any other relevant language(s)
• 12+ 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

Responsibilities

• Conducts Minor / Major / Critical Deviation investigations in their respective areas and documents such investigations.
• 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 investigations
• Reports work progress and performance metrics to Project Leader on a daily and weekly basis

Skills

Root Cause Analysis

CAPA management

Deviation investigation

Data analysis

Documentation

Project communication

Education

Bachelor’s degree in relevant field

Tools

Quality Management System (QMS)

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

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)

+12 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