The Role
Leads pharmaceutical quality assurance activities including facilities and utilities commissioning and qualification, computer system and equipment validation, risk assessments, change controls, SOPs, documentation review, data integrity, and syringe/vial inspection processes. Uses KNEAT, CDOCS, SCADA, TrackWise, and Maximo. Requires bilingual Spanish and English communication and substantial directly related experience based on education level.
Summary Generated by Built In
Sr Specialist QA with experience in:
- 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
Requirements
- Doctorate + 2 years of directly related experience or
Masters + 4 years of directly related experience or
Bachelors + 6 years of directly related experience or
Associates + 10 years of directly related experience - Bilingual (Spanish/Engilsh)
- Strong knowledge in Decision Making Techniques
Skills Required
- Doctorate with 2 years of directly related experience, or master's degree with 4 years, bachelor's degree with 6 years, or associate degree with 10 years
- Bilingual Spanish and English
- Strong knowledge of decision-making techniques
- Experience with facilities and utilities commissioning and qualification
- Experience with computer system validation
- Experience with equipment validation
- Experience with risk assessments and risk management
- Knowledge of Good Documentation Practices and data integrity
- Experience with change controls and standard operating procedures
- Experience with syringe and vial inspection processes
- Experience with document revision and approval
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
