Project Manager - Remediation
Project Manager - Remediation
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Job Description
For Remediation services in the Quality Assurance area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelors Degree in Engineering or Science and three (3) years of experience in quality assurance or systems in the regulatedindustry.
- Bilingual: Spanish and English
- Soft Skills: Attention to detail organization and writing skills.
- Shift: Administrative and according to business
- Experience:
- Project Management - Quality remediation activities.
- Rework qualification document revision & CAPA.
- Risk assessments document change management and compliance improvements.
- Electronic quality management systems (eQMS)
- FDA GMP & ISO regulations.
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one 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 take on this new challenge
AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)
- Oversee and coordinate product and process rework projects ensuring compliance with approved protocols and regulatory requirements.
- Manage the review and revision of controlled documents (e.g. SOPs work instructions protocols batch records) as part of remediation project deliverables ensuring timely completion and stakeholder approval.
- Lead impact assessments and risk analysis initiatives for nonconformances and historical deviations coordinating resources and timelines to meet project objectives.
- Ensure project changes are documented and tracked appropriately maintaining traceability justification and alignment with quality standards throughout the project lifecycle.
- Coordinate and facilitate cross-functional team collaboration (Engineering QA Manufacturing) to gather required technical inputs manage dependencies and resolve project bottlenecks.
- Oversee root cause investigation projects and manage the implementation of corrective and preventive actions (CAPAs) including resource allocation timeline management and progress tracking.
- Maintain comprehensive project documentation of all remediation activities manage project schedules ensure milestone completion and provide regular status updates to stakeholders and leadership.
WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves on how 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 the well-being of our resources while providing our Pharmaceutical medical device and Manufacturing industryclients with top-notch quality talent.Were FITS!
Are you the next piece
Required Experience:
Manager
Employment Type
Contract
