Sr. Specialist QA

FITS LLC · Other US Location

Company

FITS LLC

Location

Other US Location

Type

Full Time

Job Description

For technical services in the Facilities & Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree with eight (8) years of directly experience as Quality Professional in the regulated industry.
  • Bilingual (English & Spanish)
  • Project Management skills.
  • Shift: Administrative and according to business needs.
  • Experience in:
    • Documentation Changes.
    • Pest Control Program.
    • Deviations and CAPAS.
    • Change Controls.

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

  • Facilitate and manage documentation changes related to facilities and engineering processes.
  • Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
  • Collaborate with relevant stakeholders to implement documentation changes efficiently.
  • Provide support to the pest control program to maintain a pest-free environment within the facility.
  • Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
  • Support the documentation and records related to the pest control program.
  • Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures(SOPs).
  • Work closely with the Quality team to initiate and implement effective Corrective and Preventive Actions (CAPAs).
  • Monitor and track the progress of Deviations and CAPAs, ensuring timely closure and compliance.
  • Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
  • Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
  • Maintain Change Control records and provide support during regulatory inspections.

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?

Apply Now

Date Posted

09/21/2024

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