Specialist Quality Control

4w1 month ago

FITS, LLC

Juncos, PR · Contract · $65,000 – $90,000

About this role

This Specialist Quality Control role with FITS, LLC is based in the QC Services laboratory area at our Juncos, PR location. You will provide technical guidance and ensure flow of communication between technical groups, resolving issues as they arise within the pharmaceutical environment.

Day-to-day responsibilities include resolving technical issues and troubleshooting assays, ensuring lab compliance with GMP, GLP, and safety procedures, and managing or developing new programs and methodologies. You will also develop, revise, and audit complex controlled documents with potential multi-site impact, and may lead audit teams or serve as a subject matter expert for technical training.

Our team offers an environment of healthy competition, teamwork, and ethical scientific method application. You'll have all the lab equipment needed to put your multitasking, scientific, and creative problem-solving skills to work in a setting that values collaboration and professional growth.

As a flexible, family-oriented company, we integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the island and the US. We are focused on our resources' well-being while providing top-notch quality talent to Pharmaceutical, Medical Device, and Manufacturing clients.

Requirements

Bachelor's Degree with five years of experience within the pharmaceutical or regulated industry
Bilingual (English & Spanish)
Project Management skills
Experience in Method Validation, Method Transfer, and Method Qualification
Scientific, Chemistry, or Microbiology background
Ability to work administrative shift according to business needs

Responsibilities

Provide technical guidance, reports, and data analysis, ensuring flow of communication between technical groups and following up on and resolving issues
Resolve technical issues and troubleshoot for assays as necessary
Ensure lab compliance by implementing procedures that enhance GMP, GLP, and safety
Manage existing and develop new programs, processes, and methodologies
Develop, revise, and audit various complex controlled documents with multi-organizational or multi-site impact
Approve lab investigations and lead audit teams
May interact with regulatory agencies regarding areas of responsibility including written responses
May supervise employees as necessary to meet technical requirements

Benefits

Flexible, family-oriented company culture
Focus on resources' well-being
Opportunity to integrate engineering, construction, maintenance, utilities, and specialized technical services
Work with top-notch pharmaceutical, medical device, and manufacturing clients