Quality, Lead Investigator

FITS LLC; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

FITS LLC is seeking a qualified Compliance professional for the Quality area. The role requires a Bachelor’s degree in Chemical Engineering, Biology, or Microbiology and 5+ years in pharmaceutical manufacturing, with fluency in English and Spanish.

You will drive investigations, change control, CAPA development, and process validations, while supporting regulatory submissions and documentation. This position emphasizes teamwork and continuous improvement within a service-focused environment.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biology, or Microbiology with five or more years in the Pharmaceutical Manufacturing industry.
• Bilingual in English and Spanish.
• Experience in Manufacturing Investigations, Change Control, developing, implementing, and tracking CAPAs, Procedures Development and Revisions, and Process Validations.

Responsibilities

• Ensure that QEs, NTRs, NOES, and CAPAs are completed/closed within established timeframes using appropriate tools.
• Review and provide input to regulatory submissions applicable to the area of responsibility.
• Lead QE and CAPA trend evaluation.
• Participate in new product introduction to determine documentation, training, and equipment modification needs.
• Support establishment of process monitoring parameters and control limits.
• Assess deviations and process monitoring data.
• Monitor and evaluate parameters in ongoing processes to optimize times, productivity, equipment performance, yields, and quality.
• Provide technical assistance to identify and implement process/equipment modifications and cost-reduction projects.

Skills

Bilingual English/Spanish

Regulatory knowledge

CAPA management

Process optimization

Education

Bachelor's degree in Chemical Engineering, Biology, or Microbiology

Tools

SOP writing

Job description

For Compliance services in the Quality area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degreein ChemicalEngineering, Biology, or Microbiology Science & five (5) years of experiencein the Pharmaceutical Manufacturing industry.
• Bilingual (English & Spanish)
• Experience in:
  • Manufacturing Investigations
  • Change Control
  • Developing, implementing, and tracking CAPAs.
  • Procedures Development and Revisions.
  • Process Validations

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)

• Ensures that all QEs, NTRs, NOES,and CAPAsare completed/closedwithin the established timeframe, utilizing the right tools to prevent reoccurrence.
• Reviews and provides input to regulatory submissions applicable to the area of responsibility.
• Leads QE’s and CAPA’s trend evaluation.
• Participates in the new product introduction process to determine requirements for documentation, materials, training, and equipment modifications.
• Supports the establishment of process monitoring parameters and control limits.
• Supports the assessment of deviations and process monitoring data.
• Monitors and evaluates parameters in existing (on-going) processes to optimize process times/productivity, equipment performance, yields, and quality.
• Provides technical assistance to identify, recommend, and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects, and ensurethe manufacturing area complies.
• Write, evaluate, and revise the required manufacturing documentation (i.e. SOPs, MBRs, etc.) and may assist in providing training on scientific or technical aspects of the processes
• Assists with the generation and execution of validation protocols and reports.
• Participates in regulatory inspection when necessary
• Assists the area managers and supervisory personnel to solve any production technical problem (i.e., Process/equipmenttroubleshooting, yield, cycle time, quality, and productivity).
• Provides alternatives and recommendations to improve and maximize processes and equipment.
• Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
• Promotes and models the client's Core Behaviors, facilitating teamwork.
• Supports all site Initiatives and any other assignments based on business needs.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves onhow 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 industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?