Pharma QA Specialist - NPI, CAPA, Audits, Validation

FITS LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a senior QA professional to join our pharmaceutical services team. The role focuses on QA review, process validation, and site quality oversight in a regulated environment.

You will collaborate with cross-functional teams, lead investigations, and ensure CAPA and change-control processes are compliant with cGMP standards while coordinating with manufacturing and automation initiatives.

Qualifications

• Bachelor's degree with five (5) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Non Standard Shift and according to business needs. Available to work AM (5am to 5pm) and Night (5:00pm-5:00AM)
• Experience in: Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing method.
• Batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise.
• Quality Systems such as deviations, CAPA, and change control.
• Validation Process.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems. Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations. Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities. Support facilities and 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

Bachelor's degree

Bilingual (English & Spanish)

Project Management

QA experience

Leadership

Regulatory compliance

Quality Systems

Validation

Shift availability

Education

Bachelor's degree in Pharmaceutical/regulated industry

Tools

SAP

MES

EDMQ

DQMS

Trackwise

Job description

FITS LLC in Puerto Rico is seeking a senior QA professional to join our pharmaceutical services team. The role focuses on QA review, process validation, and site quality oversight in a regulated environment.

You will collaborate with cross-functional teams, lead investigations, and ensure CAPA and change-control processes are compliant with cGMP standards while coordinating with manufacturing and automation initiatives.