Biotech Manufacturing Specialist — Process & Quality

Inteldot; Juncos (PR); On-site; USD 80,000 - 120,000; Full time

Job summary

Inteldot is seeking an Administrative Shift professional to support manufacturing and quality systems in a biotech environment. The role involves deviations handling, procedure ownership, and process optimization under minimal supervision.

Responsibilities include contributing to CAPA, training material development, and regulatory inspection support to ensure compliant operations across Puerto Rico and the broader site network.

Qualifications

• Deviations management and assessment experience in biopharma or biotech manufacturing.
• Familiarity with TrackWise or equivalent quality systems.
• Experience supporting regulatory inspections and CAPA processes.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and serve as document owner.
• Assess process performance and implement improvements based on data.
• Provide troubleshooting support for manufacturing operations.
• Assist in training materials and training on technical processes.
• Support process monitoring, data collection, and quarterly reports.
• Contribute to NC/CAPA investigations and closure within goals.
• Review investigations and support trend evaluations for equipment/processes.
• Assist with process validation protocols, reports, and data.

Skills

Deviations management

Deviation assessments

TrackWise

Biotech and manufacturing experience

Education

Doctorate

Master's + 2 years of Manufacturing Operations experience

Bachelor's + 4 years of Manufacturing Operations experience

Associate + 8 years of Manufacturing Operations experience

High school/GED + 10 years of Manufacturing Operations experience

Job description

Inteldot is seeking an Administrative Shift professional to support manufacturing and quality systems in a biotech environment. The role involves deviations handling, procedure ownership, and process optimization under minimal supervision.

Responsibilities include contributing to CAPA, training material development, and regulatory inspection support to ensure compliant operations across Puerto Rico and the broader site network.