Quality Specialist – Drug Substance | Process & Compliance

FITS LLC; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Job summary

FITS seeks a QA professional for the Drug Substance area, responsible for reviewing product MPs, approving validation protocols, and leading site audits in a dynamic pharmaceutical environment in Puerto Rico.

The role requires a Bachelor’s degree with 4 years' experience, bilingual English/Spanish, and strong project management skills; the candidate will own site quality procedures and support environmental and automation programs.

Qualifications

• Bachelor's degree with four years of experience in pharmaceutical or regulated industry.
• Bilingual English and Spanish.
• Project management skills.
• Experience in Quality and Manufacturing operations.
• Experience with batch record review, documentation compliance, electronic systems management, inventory control, and timely operations.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Coordinate with incident triage team for Quality.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems and approve planned incidents.
• Represent QA on NPI team.
• Lead investigations and site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support automation activities and facilities/environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

Bilingual English & Spanish

Project management

Quality & Manufacturing ops

Batch Record Review

Education

Bachelor's Degree

Tools

Electronic systems management

Job description

FITS seeks a QA professional for the Drug Substance area, responsible for reviewing product MPs, approving validation protocols, and leading site audits in a dynamic pharmaceutical environment in Puerto Rico.

The role requires a Bachelor’s degree with 4 years' experience, bilingual English/Spanish, and strong project management skills; the candidate will own site quality procedures and support environmental and automation programs.