Specialist Quality Assurance

Flexible & Integrated Technical Services, LLC • Juncos, PR

12d • Onsite

About The Position

We are seeking a Specialist Quality Assurance for QA Services in the Downstream area. This role requires a blend of technical expertise and personal attributes suited for a dynamic, team-oriented environment. The ideal candidate will be adept at multitasking, possess strong scientific and analytical skills, and be committed to ethical practices and the scientific method.

Requirements

• Bachelor's Degree with five (5) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Environmental Monitoring, Microbial Identification, Critical Utilities, and Cleanroom Contamination Control.
• Knowledge of Quality Standards and Regulations (Annex 1, FDA Guidance, ISO - 14644-1, and USP).
• Experience with Data trending, statistical analysis, and electronic platforms (Veeva, Spotfire, LIMS, Maximo).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level