Lead Quality Investigator – CAPA & Compliance

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

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.