JT033 - SPECIALIST QA

Quality Consulting Group • Juncos, PR

2d

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

• Bachelor’s degree in Life Sciences or Engineering (Engineering background preferred; Life Sciences accepted)
• Strong knowledge and hands-on experience with Aseptic manufacturing processes
• Change Control Experience
• Minimum 4+ years of directly related QA experience in a regulated manufacturing environment
• Proven experience with NPI, Change Control, FATs, Validation, PPQs, and Cleaning Validation
• Manufacturing and laboratory experience required
• Demonstrated expertise in GMP documentation practices, including protocol/report review, investigations, and regulatory submissions
• Strong understanding of manufacturing, distribution, QA/QC/QAL, validation, and process development activities
• Experience interacting with regulatory agencies and supporting inspections
• Solid project management skills with the ability to manage multiple priorities
• Administrative shift but available for extra hours if needed.

Responsibilities

• Review, approve, and maintain manufacturing process documentation (MPs) in compliance with cGMP requirements
• Review, approve, and ensure accuracy, completeness, and traceability of GMP documentation, including protocols, reports, investigations, and quality records
• Approve process validation protocols and reports, including PPQs and cleaning validation documentation
• Participate as Quality representative on incident triage teams, ensuring timely and compliant decision-making
• Review and approve planned incidents, deviations, and nonconformances, ensuring appropriate risk assessment and documentation
• Approve Environmental Characterization and environmental monitoring reports
• Release and maintain compliance of sanitary utility systems
• Represent Quality Assurance on New Product Introduction (NPI) teams
• Lead and document investigations, root cause analyses, and CAPA development
• Lead and support site audits, including internal, external, and regulatory inspections
• Own, maintain, and continuously improve site quality program procedures
• Serve as QA Manager designee on the local Change Control Review Board (CCRB)
• Review and approve risk assessments and mitigation strategies
• Support automation systems, including review of validation and change documentation
• Support facilities, utilities, and environmental compliance programs
• Review and approve work orders, ensuring GMP and quality alignment
• Review, assess, and approve EMS/BMS alarms and associated quality documentation
• Review and approve NC investigations, CAPAs, and effectiveness checks
• Review, approve, and manage change controls across manufacturing, laboratory, and support systems
• Perform lot disposition and authorize product release for shipment

What This Job Offers

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