Quality, Investigator
Quality, Investigator
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Job Description
For Quality services in the Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degreein Engineering or Life Sciences& five (5) years of experiencein the Pharmaceutical Manufacturing industry.
- Bilingual (English & Spanish)
- Experience in:
- Pharmaceutical industry with emphasis on root cause analysis investigations and quality systems.
- Parenteral manufacturing.
- Technical writing
- Cross-functional investigations for manufacturing equipment and utilities failures environmental excursions pest control maintenance systems human error and other quality events.
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team members. In other words being a customer service pro is one of your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate always bringing top-quality results to the table. Are you ready to Be The Piece
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- In a timely manner lead cross-functional investigations for manufacturing equipment and utilities failures environmental excursions pest control maintenance systems human error and other quality events.
- Apply structured problem-solving tools (e.g. 5 Whys Fishbone Diagram Fault Tree Analysis) to identify true root causes.
- Collaborate with Manufacturing Quality Control Engineering and other departments to gather data and insights.
- Draft clear concise and scientifically sound investigation reports in compliance with cGMP and regulatory expectations.
- Negotiate recommendand track CAPAs to ensure timely and effective implementation.
- Participate in continuous improvement initiatives to reduce recurring deviations and improve engineering processes.
- Supports pre-inspection requests and walkthroughs.
- Support Site and Departments regulatory inspections and audits.
- Completeresponses for audit findings.
- Support Engineering Trainings Programs.
- ReviseSOPs and lead participate in improvements initiatives for the Engineering Department.
- Completequality records on time: CAPAs Standalone Actions Effectiveness Checks etc.
- LeadChange Controls: Present in local review board and act as change control owner up to change implementation.
- Maintain Quality / Compliance metrics of the Engineering Department including investigations and contributes to trend analysis and reporting.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves onhow we treat the most important piece of our companys 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.Were FITS!
Are you the Next Piece
Required Experience:
Senior IC
Employment Type
Contract
