Quality Lead Investigator: CAPA & Change Control

FITS, LLC; Manatí (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

FITS, LLC invites a compliance specialist to join our Quality team on the Puerto Rico site in Manatí. You will drive manufacturing quality improvements by leading investigations, change control, CAPA programs, and regulatory submissions.

You will collaborate across functions to ensure procedures, validations, and process controls meet demanding pharmaceutical standards. The ideal candidate has a degree in Chemical Engineering, Biology, or Microbiology and at least five years in pharma

Qualifications

• Bachelor’s Degree in Chemical Engineering, Biology, or Microbiology and five years of experience in the Pharmaceutical Manufacturing industry.
• Experience in Manufacturing Investigations, Change Control, and developing, implementing, and tracking CAPAs.
• Procedures development and revisions; Process Validations in pharma.
• Strong commitment to quality, safety, and regulatory compliance.

Responsibilities

• Ensures that all QEs, NTRs, NOES, and CAPAs are completed/closed within 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 processes to optimize 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.

Skills

Pharma manufacturing experience

Education

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

Job description

FITS, LLC invites a compliance specialist to join our Quality team on the Puerto Rico site in Manatí. You will drive manufacturing quality improvements by leading investigations, change control, CAPA programs, and regulatory submissions.

You will collaborate across functions to ensure procedures, validations, and process controls meet demanding pharmaceutical standards. The ideal candidate has a degree in Chemical Engineering, Biology, or Microbiology and at least five years in pharma