Supplier Quality Specialist

FITS LLC; Juncos (PR); Hybrid; USD 70,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Quality Systems specialist to own supplier change control within a biopharmaceutical manufacturing setting. You will assess changes to raw materials or components and ensure documentation and implementation are completed.

This remote role requires on-site audits as needed. You will track change controls in TrackWise and SAP, triage non-conformances, and drive CAPA closures. Fluency in English and Spanish and project management skills are required.

Qualifications

• Bachelor's degree in a science field with 4+ years in pharma or regulated industry.
• Fluent in English and Spanish.
• PM skills and experience with change control.

Responsibilities

• Own supplier-related change controls from initiation through closure.
• Assess supplier change notifications and quality records for impact on materials and product quality.
• Initiate, revise, and approve manufacturing procedures and raw material documentation affected by supplier changes.
• Track and document change control activities in TrackWise and SAP.
• Triage supplier-related non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established goals.
• Monitor supplier incident trends and assist in training materials related to changes.

Skills

Project management

Bilingual English/Spanish

Quality systems

Change control

Education

Bachelor's degree in science

Tools

TrackWise

SAP

Job description

For Manufacturing Services in the Quality Systems area, supporting supplier and raw material change control.

WHAT MAKES YOU A FIT:

Join the Quality Systems area of a biopharmaceutical manufacturing operation as the owner of supplier change control. In this role, you’ll ensureevery change to a raw material or component is assessed, documented, and implemented correctly, and you’ll manage supplier-related non-conformances and CAPAs through closure.

The Technical Part:

• Bachelor'sDegree in a Science,with four (4) years of experience asa Scientist inthe pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative,asneeded.
• Work Model: Remote, with on-site presence required for audits as needed.
• Experience in:
  • Change Control processes, including supplier change notifications and impact assessments of supplier-related quality records
  • Raw materials and components, including specifications and material documentation
  • TrackWise and SAP
  • Non-conformance/CAPA investigation authoring and closure management

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical, and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Own supplier-related change controls from initiation through closure, ensuring timely and compliant implementation.
• Assess supplier change notifications and quality records to determine their impact on raw materials, processes, and product quality, coordinating with Supplier Quality, Materials Management, Quality Control, and Manufacturing.
• Initiate, revise, and approve manufacturing procedures and raw material documentation affected by supplier changes. Serve as a document owner.
• Track and document change control activities in TrackWise and SAP.
• Ensure all supplier-related Non-conformances are triaged within the established goal.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within established goal.
• Monitor and communicate supplier and incident trends.
• Assist in the generation of training materials related to process and material changes.

WHO WE ARE:

We are a Service Provider companydifferent 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!

Are you the next piece?