Operation Process Support Specialist

Operation Process Support Specialist

Fits Llc





Operation Process Support Specialist

Detalles de la oferta

For Investigation services in the Manufacturing area

The Technical Part:
Bachelor's degree in Science, pharmacy and/or Engineering & five (5) years of exposure in the Parenteral Manufacturing Facility.

Experience in:
Analyzing statistical data.
CGMP's, OSHA, EPA and other regulatory standards.
Communication (Spanish /English).
Providing operational and scientific support to the Manufacturing Sterile Operations.

The Personality Part:
If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we're looking for!

AS A PIECE OF FITS, YOU WILL:(The day-to-day on the job)
Ensure that all QE's, NTR's, NOE's and CAPA's are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
Participate in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications.
Support establishment of process monitoring parameters and control limits.
Support the assessment of deviations and process monitoring data.
Monitor and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields and quality.
Write, evaluate and revise the manufacturing documentation (SOP's, MBR's, etc.) and may assist in providing training on scientific or technical aspects of the processes.
Assist with generation and execution of validation protocols and reports.
Assist the area managers and supervisory personnel to solve any production technical problem (Process, equipment troubleshooting, yield, cycle time, quality and productivity).
Provide alternatives and recommendations to improve and maximize processes and equipment's.
Participate in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation

One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you'll be amazed). However, that's not all we have to offer. Talk with us to find out!

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?


Fuente: Simplyhired




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