Specialist Manufacturing

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d

About The Position

For Manufacturing Services in the Quality Systems area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Shift: Administrative and according to business needs.
Experience in:
Process Manufacturing.
Managing CAPA and Change Controls.
Document revision.
VEEVA.
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 company different 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 industry clients with top-notch quality talent. We're FITS!
Are you the next piece?

Requirements

• Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Process Manufacturing.
• Managing CAPA and Change Controls.
• Document revision.
• VEEVA.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level