Pharma Quality Complaints Investigator

FITS LLC; Juncos (PR); Hybrid; USD 55,000 - 85,000; Full time

Job summary

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you!

We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Qualifications

• Bachelor’s degree in Quality or Engineering with four years of directly related experience in the Pharmaceutical industry.
• Fluent in English.
• Project Management skills.
• Shift: Administrative (as needed by the business).
• Experience in: Project Management, Root Cause Analysis, CAPA determination.
• Quality mindset and deep compliance knowledge.
• Proficient in Microsoft Office programs (Excel, Outlook), and use of Teams.

Responsibilities

• Keep the complaints database updated as soon as factual information is available, and summarize closed investigations into the database accurately.
• Ensure complaint-related investigations are concise, clear, and science-based by reviewing and approving such investigations.
• Follow upon corrective actions derived from investigations through completion.
• On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible for conducting and documenting the investigation.
• Possess excellent writing skills that include closing the gap between a highly technical investigation and a simple and concise document that can be understood by non-technical reviewers.
• Communication and escalation of complaints, site representation on the product complaint network, and generation and issuance of closure letters to patients and business partners.

Skills

Fluent English

Project Management

Root Cause Analysis

CAPA management

Quality mindset

MS Office

Teams

Education

Bachelor's degree in Quality or Engineering

Tools

Excel

Outlook

Teams

Job description

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you!

We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!