JT711 - SR. SPECIALIST QA

Quality Consulting Group • Juncos, PR

8d

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 and 6 years of directly related experience
• Facilities and Utilities Commissioning and Qualification,
• Computer System Validation,
• Equipment validation,
• Risk Assessments,
• KNEAT,CDOCS, SCADA, TRACKWISE,MAXIMO
• Good Documentation Practices, Data Integrity
• Change Controls,
• Standard Operation Procedure
• Syringe/Vials Inspection Process
• Documents revision and approval
• Strong knowledge in Decision Making Techniques
• Risk Management applicable procedures, quality standards, and regulatory requirements.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.

Responsibilities

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Project management skills.

What This Job Offers

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