Lead Deviation Investigator & CAPA Specialist (GMP)

GlaxoSmithKline plc; Upper Merion Township (Montgomery County); On-site; USD 65,000 - 90,000; Full time

Job summary

GlaxoSmithKline plc is seeking an Associate Site Investigation Specialist for a 5-day on-site role at a US manufacturing or laboratory site. You will act as the lead investigator for deviations, perform root-cause analysis, and develop CAPAs in alignment with GSK standards.

The role requires a GMP-regulated manufacturing background (1+ year) and Orange Belt certification. You will collaborate with QA, engineering and production teams and ensure documentation adheres to ALCOA principles.

Qualifications

• Bachelor of Arts or Bachelor of Science.
• 1+ years of experience in a GMP-regulated manufacturing environment or related industry, with experience executing production processes, supporting manufacturing operations, adhering to quality and compliance requirements, and performing assigned technical or operational tasks.
• Orange Belt Certification will be required to successfully perform the role.

Responsibilities

• Lead Investigator for deviations using standardized processes and training.
• Apply DMAIC and GPS tools to improve efficiency and prevent non-compliance.
• Investigate deviations, non-conformances and quality events, collecting and analyzing data.
• Identify root causes and implement CAPAs.
• Collaborate with cross-functional teams to gather information and support CAPA implementation.
• Prepare investigation reports documenting findings, root causes and CAPAs.
• Act as expert in VQMS for tracking, managing, and documenting investigations and provide training.
• Deliver training on investigation processes and root cause analysis techniques.
• Adhere to ALCOA principles for documentation.
• Own deviation and environmental monitoring investigations, write-ups, CAPA management, impact assessments, and simple change controls.

Skills

Bioprocessing

Cell Line Development

Experimental Methods

Technical Writing

Technology Transfer

Education

Bachelor of Arts or Bachelor of Science.

Bachelors of Science, Engineering or Biotechnology.

Job description

GlaxoSmithKline plc is seeking an Associate Site Investigation Specialist for a 5-day on-site role at a US manufacturing or laboratory site. You will act as the lead investigator for deviations, perform root-cause analysis, and develop CAPAs in alignment with GSK standards.

The role requires a GMP-regulated manufacturing background (1+ year) and Orange Belt certification. You will collaborate with QA, engineering and production teams and ensure documentation adheres to ALCOA principles.