The Role
Provide technical Quality Assurance leadership across manufacturing and site quality programs. Responsibilities include approving process validation, environmental characterization, sanitary utility release, planned incidents, and product documentation; leading investigations; participating in incident triage and new product introduction teams; and owning quality procedures. The role requires expertise in commissioning and qualification, computer and equipment validation, risk management, data integrity, change controls, documentation practices, and regulated pharmaceutical inspection processes.
Summary Generated by Built In
We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs.
FUNCTIONS
- 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.
Requirements
Education: 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 or High school/GED + 12 years of directly related experience.
Experience with:
- 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 of Decision Making Techniques
- Risk Management
Skills Required
- Doctorate degree plus 2 years of directly related experience
- Master's degree plus 4 years of directly related experience
- Bachelor's degree plus 6 years of directly related experience
- Associate's degree plus 10 years of directly related experience
- High school diploma or GED plus 12 years of directly related experience
- Experience with facilities and utilities commissioning and qualification
- Experience with computer system validation
- Experience with equipment validation
- Experience with risk assessments and risk management
- Experience with KNEAT, CDOCS, SCADA, TrackWise, and Maximo
- 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
- Strong knowledge of decision-making techniques
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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.
