Quality Investigator Lead — CAPA & Process Excellence

FITS LLC; Manatí (PR); Presencial; USD 85 000 - 110 000; Tempo integral

Resumo da oferta

FITS LLC is seeking a QA/Compliance professional to support the Quality area in pharmaceutical manufacturing. The role emphasizes investigations, CAPAs, change control, and process validations while fostering teamwork and client service excellence.

The ideal candidate will hold a Bachelor’s degree in Chemical Engineering, Biology, or Microbiology with 5 years of relevant experience, and will collaborate with cross-functional teams to ensure regulatory readiness and continuous process improvement

Qualificações

• Bachelor’s degree in Chemical Engineering, Biology, or Microbiology with 5 years in Pharmaceutical Manufacturing.
• Experience in Manufacturing Investigations, Change Control, CAPAs, Procedures Development/Revisions, and Process Validations.

Responsabilidades

• Ensure QE’s, NTRs, NOEs, and CAPAs are completed/closed within established timeframes.
• Lead trend evaluation for QEs and CAPAs.
• Support documentation for regulatory submissions and training.
• Assist with qualification/validation protocols and reports.
• Solve production technical problems with engineers and operators.
• Contribute to process monitoring, deviations assessment, and cost-reduction initiatives.

Conhecimentos

Customer service

Team collaboration

Process improvement

Formação académica

Bachelor’s Degree in Chemical Engineering, Biology, or Microbiology

Descrição da oferta de emprego

FITS LLC is seeking a QA/Compliance professional to support the Quality area in pharmaceutical manufacturing. The role emphasizes investigations, CAPAs, change control, and process validations while fostering teamwork and client service excellence.

The ideal candidate will hold a Bachelor’s degree in Chemical Engineering, Biology, or Microbiology with 5 years of relevant experience, and will collaborate with cross-functional teams to ensure regulatory readiness and continuous process improvement