Investigation Specialist

Stark Pharma Solutions Inc; Indianapolis (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking an experienced Investigation Specialist to support quality investigations within a GMP-regulated pharmaceutical manufacturing environment. The role focuses on root cause analysis, documenting investigations, and implementing effective CAPA.

You will lead deviation and non-conformance investigations, review manufacturing events, develop corrective actions, and ensure compliance with GMP and FDA requirements while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences.
• Experience in pharmaceutical/biotech manufacturing or quality.
• Experience with GMP, deviations, investigations, RCA, and CAPA.
• Experience with electronic quality management systems (eQMS) preferred.

Responsibilities

• Lead and support deviation, non-conformance, and quality investigations.
• Perform Root Cause Analysis (RCA) using 5-Why, Fishbone, and other methodologies.
• Review manufacturing, laboratory, equipment, and process-related events.
• Develop and implement CAPA and effectiveness checks.
• Prepare clear investigation reports and supporting documentation.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and other teams.
• Ensure investigations comply with GMP, FDA, and company quality requirements.
• Maintain accurate investigation and quality documentation.

Skills

Root Cause Analysis

CAPA

GMP Knowledge

Documentation

Cross-functional Collaboration

Analytical Thinking

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences

Tools

eQMS

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Investigation Specialist

Location: Indiana, USA

Duration: Long Term

Job Overview

We are seeking an experienced Investigation Specialist to support quality investigations within a GMP-regulated pharmaceutical manufacturing environment. The role will focus on identifying root causes, documenting investigations, and implementing effective corrective and preventive actions.

Key Responsibilities

• Lead and support deviation, non-conformance, and quality investigations.
• Perform Root Cause Analysis (RCA) using 5-Why, Fishbone, and other quality methodologies.
• Review manufacturing, laboratory, equipment, and process-related events.
• Develop and implement CAPA and effectiveness checks.
• Prepare clear and accurate investigation reports and supporting documentation.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and other cross-functional teams.
• Ensure investigations comply with GMP, FDA, and company quality requirements.
• Maintain accurate investigation and quality documentation.

Required Qualifications

• Bachelor s degree in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or a related field.
• Experience in pharmaceutical/biotech manufacturing or Quality.
• Strong knowledge of GMP, deviations, investigations, RCA, and CAPA.
• Experience with quality investigation and documentation processes.
• Experience With Electronic Quality Management Systems (eQMS) Is Preferred.
• Strong analytical and problem-solving skills.
• Excellent documentation and communication skills.
• Ability to work effectively with cross-functional teams.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.