GMP Deviation Investigator | Quality & CAPA Lead

Actalent; Wilson (NC); In loco; USD 57.000 - 81.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical/Dental/Vision

401(k)

PTO/Vacation

Life Insurance

Disability

HSA

Transit benefits

Descrizione del lavoro

Actalent is seeking a Deviation Investigator in Wilson, NC to identify, document, and investigate deviations from SOPs and regulatory requirements in a GMP/aseptic environment.

The role focuses on root cause analysis, CAPA development, and maintaining compliant records, with work on isolator lines and cross-functional collaboration. It is a 12-month, fully onsite contract with potential for permanent conversion.

Competenze

• 2+ years in pharmaceutical investigations under GMP.
• Strong GMP principles applied to deviation management.
• Proven root cause analysis experience (fishbone, 5 Whys).
• Ability to write clear, compliant investigation reports.
• Experience in aseptic environments and isolator lines.

Mansioni

• Identify and document deviations from SOPs, quality standards, and regulatory guidelines.
• Conduct structured investigations to determine root cause using established methodologies.
• Collaborate with cross-functional teams to develop CAPAs addressing root causes.
• Implement and track CAPAs to ensure on-time completion and effectiveness.
• Maintain GDP-compliant records of deviations, investigations, and CAPAs.

Conoscenze

GMP knowledge

Root cause analysis

CAPA development

Technical writing

Aseptic investigations

Documentation

Cross-functional collaboration

Strumenti

GxP documentation systems

CAPA systems

Descrizione del lavoro

Actalent is seeking a Deviation Investigator in Wilson, NC to identify, document, and investigate deviations from SOPs and regulatory requirements in a GMP/aseptic environment.

The role focuses on root cause analysis, CAPA development, and maintaining compliant records, with work on isolator lines and cross-functional collaboration. It is a 12-month, fully onsite contract with potential for permanent conversion.