Empleos actuales relacionados con Sr. Quality Systems Specialist - Juncos - Flexible & Integrated Technical Services, LLC

  • Specialist QA

    hace 2 semanas


    Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

    The Quality Assurance Specialist provides quality oversight and support for regulated manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality systems. This role performs QA review, approval, and leadership activities under minimal supervision and serves as a key quality...


  • Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

    The QA Associate, Quality Operations is a floor-facing Quality Assurance role that supports day-to-day manufacturing operations in a GMP-regulated environment. This position was opened due to increased team activity and requires strong collaboration with cross-functional partners across Manufacturing, Quality Control, Validation, Engineering, Facilities, and...

Sr. Quality Systems Specialist

hace 20 minutos


Juncos, Puerto Rico Flexible & Integrated Technical Services, LLC A tiempo completo

For Engineer services in the Quality area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree in Engineering and three (3) years of exposure within the Pharmaceutical & Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Excellent Communication skills, and Positive attitude. 
  • Shift: 1st Shift
  • Experience in:
    • Process Validation and Computer Software Validation.
    • Technical writing knowledge
    • Organization and communication
    • Investigation and Root Cause Analysis. 

The Personality Part:    

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages.
  • Coordinates legal requests in support of government investigations or litigations.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of the company's mission globally. 

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?