Investigation Specialist
Listed on 2026-10-15
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Quality Assurance - QA/QC
Quality Engineering, QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
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 OverviewWe 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.
- 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.
- 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.
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