Project Manager - Remediation

For Remediation services in the Quality Assurance area.  WHAT MAKES YOU A FIT :   The Technical Part : Bachelor’s Degree in Engineering or Science and three (3) years of experience in quality assurance or systems in the regulated industry.  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 members.

In other words, being a customer service pro is one your (many) talents.

Being the Piece means you're 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 company different from the rest.

We pride ourselves on 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 the well-being of our resources, while providing our Pharmaceutical, medical device, and Manufacturing industry clients with top-notch quality talent.  We're FITS!  Are you the next piece?

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