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Investigation Specialist
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AutoPak Engineering
Full-Time
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Job Description
Investigation Specialist
Gurabo, PR
Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. For 2 decades, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets. Overview
The Investigation Specialist is responsible for overseeing, conducting, and documenting investigations related to deviations, nonconformances, and quality events. This role ensures timely, thorough, and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). Key Responsibilities
1. Perform investigations for deviations and quality events
2. Gather and analyze data, interview personnel, and review documentation to understand event details
3. Apply structured root cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone,etc.)
4. Ensure investigations are completed within required timelines and meet regulatory and internal qualitystandards.
5. Identify true root causes supported by evidence.
6. Develop effective CAPA plans that address root causes and prevent recurrence.
7. Partner with process owners to ensure CAPA implementation, effectiveness checks, and closure.
8. Prepare clear, concise, and compliant investigation report.
9. Ensure documentation meets GMP, and regulatory expectations.
10. Maintain high standards of accuracy, clarity, and traceability.
11. Work closely with Operations, Quality Assurance, Engineering and other departments.
12. Facilitate investigation meetings and cross functional problem solving sessions as required.
13. Support technical issues as required.
Education:
Bachelor's degree in science and/or 3- 5 years of Quality Investigations experience Required Knowledge & Skills- Knowledge of Facilities/Utilities operations is preferred
- Strong understanding of GMP, GDP, and regulatory expectations.
- Expertise in root cause analysis tools and structured problem solving.
- Proficiency in CAPA development, implementation, and effectiveness evaluation.
- Excellent technical writing and documentation skills.
- Ability to interpret data, trends, and process performance indicators.
- Strong communication, facilitation, and interpersonal skills.
- Ability to manage multiple investigations simultaneously and prioritize effectively