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Operation Process Support Specialist II

FITS LLC Manatí, PR

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

For services in the Production area

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor’s degree in Science, Pharmacy 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.
    • Technical Writing
    • 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 evaluate 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

BEING A FITS PIECE COMES WITH PERKS:

  • 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!

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?

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FITS LLC

Address

Manatí, PR
00674 USA

Industry

Manufacturing

View all jobs at FITS LLC