Manufacturing Specialist- 10

FITS, LLC; Juncos (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

FITS, LLC is seeking a Scientist for Manufacturing Services in Quality Systems in Puerto Rico. The role involves authoring, revising, and approving manufacturing procedures and owning related documents.

You will assess floor operations, review performance data, and implement solutions to improve processes. The position requires a Bachelor's degree with 5+ years in pharma/regulatory environments, and the ability to work administrative shifts as needed.

Qualifications

• Requires a Bachelor's degree with 5+ years as a Scientist in pharma or regulated industry.
• Administrative shift as per business needs; on-site lab environment.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and own documents.
• Assess process performance by floor observations and data reviews; implement solutions.
• Assist in training materials and deliver training on process aspects.
• Support process monitoring data collection and deviation assessments.
• Ensure timely quarterly process monitoring reports.
• Triages non-conformances within goals; author investigation reports.
• Execute corrective actions and manage NC/CAPA closures.
• Monitor incidents trends and review RCA investigations for trends.

Skills

Root Cause Analysis

Lean Manufacturing

GDP Practices

Multitasking

Scientific/technical skills

Process monitoring

Documentation ownership

Education

Bachelor's degree

Tools

Trackwise

VEEVA

MES

Smart Sheet

Power BI

Spotfire

CDOCS

ChatGPT

Copilot

Job description

For Manufacturing Services in the Quality Systems a rea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experience asa Scientistwithin the pharmaceutical or regulated industry.
• 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.
• 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!