Lead and execute laboratory investigations for OOS/OOT, deviations, and atypical results for parenteral products. Perform root cause analysis, review analytical and manufacturing data, prepare investigation reports and CAPAs, support audits/inspections, and drive continuous improvement while ensuring cGMP and data integrity compliance.
The Laboratory Investigations Scientist is responsible for conducting, documenting, and supporting investigations related to deviations, out-of-specification (OOS) results, and non-conformances associated with the testing and manufacturing of parenteral (sterile injectable) products. This role ensures compliance with cGMP regulations while supporting root cause analysis and implementing corrective and preventive actions (CAPA).
Key Responsibilities:
- Lead and support laboratory investigations for OOS, OOT (Out of Trend), deviations, and atypical results related to parenteral products.
- Perform root cause analysis using structured methodologies (e.g., fishbone diagrams, 5 Whys).
- Review analytical data, laboratory documentation, and manufacturing records to identify discrepancies.
- Collaborate with Quality Assurance, Manufacturing, Microbiology, and Analytical teams to support investigations.
- Ensure investigations are completed in a timely manner and in compliance with cGMP, FDA, and regulatory requirements.
- Prepare detailed investigation reports, including conclusions and recommended CAPAs.
- Support implementation and effectiveness checks of CAPAs.
- Participate in audit readiness activities and support inspections as needed.
- Identify opportunities for continuous improvement in laboratory processes and investigation practices.
- Maintain proper documentation practices in compliance with data integrity requirements (ALCOA principles).
Requirements
Similar Jobs
Information Technology • Software
Manage procurement and supply chain for life sciences, focusing on vendor management, contract strategies, and compliance in regulated environments.
Top Skills:
Integrated Facilities ManagementMs Office ApplicationsProcurementVendor Management
Information Technology • Insurance • Professional Services • Software
Responsible for strategy, roadmap, and execution for financial integrations. Collaborates with cross-functional teams, uses data to improve features, and manages product lifecycle.
Top Skills:
DovetailJIRA
Consulting • Pharmaceutical
The Project Manager will oversee project management deliverables, global communications, and maintain business roles and responsibilities.
Top Skills:
Pmp Certification
What you need to know about the Charlotte Tech Scene
Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.
Key Facts About Charlotte Tech
- Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
- Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
- Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
- Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus
