Manufacturing Specialist- 10

fitspr; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS PR manufactures services in the Quality Systems area and seeks a Scientist with pharma experience in Puerto Rico. The role requires bilingual English/Spanish communication, project management, and strong data-driven problem solving to improve processes on the floor.

You will own procedures, analyze performance, provide troubleshooting, and help train staff while ensuring NC/CAPA closure and timely reports in a regulated environment.

Qualifications

• Bachelor's degree with five years of experience in pharma or regulated industry.
• Bilingual in English and Spanish.
• PM skills and shift flexibility.
• Experience with quality systems and manufacturing control.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; act as document owner.
• Assess process performance and implement solutions based on data.
• Provide troubleshooting support.
• Assist in generating training materials and deliver training when needed.
• Support process monitoring parameters and control limits; collect data.
• Ensure timely execution of quarterly process-monitoring reports.
• Triage non-conformances within goals; author investigation reports.
• Execute corrective actions and manage NC/CAPA closure.
• Monitor incidents trends and review root cause investigations.

Skills

Bilingual English/Spanish

Project management

Root cause analysis

Lean manufacturing

GDP practices

TrackWise

VEEVA

MES

Power BI

Spotfire

SmartSheet

ChatGPT

Copilot

CDOCS

Education

Bachelor's degree

Tools

TrackWise

VEEVA

MES

SmartSheet

Power BI

Spotfire

CDOCS

Job description

For Manufacturing Services in the Quality Systems area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in:
  • Root Cause Analysis methodologies.
  • Lean Manufacturing and GDP Practices.
  • Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms.

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)

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

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?