Senior Specialist, Field Quality QA Operations

Role responsibilities

The Senior Field QA Specialist is responsible for maintaining quality oversight and ensuring GMP compliance in manufacturing operations. This includes reviewing Manufacturing Batch Records, conducting GMP area walkthroughs, and supporting timely return-to-service walkthroughs.

Requirements

A bachelor's degree in science, engineering, biochemistry, or a related discipline is preferred, along with 4 years of Quality Assurance experience in the pharmaceutical or medical device industry. Batch record review experience is also required.

Key skills

Quality Assurance, GMP Compliance, Manufacturing Batch Records, Analytical Testing, Biotech Manufacturing, cGMP Regulations, Electronic Systems, Documentation Compliance, Training, Problem Solving, Inspection Readiness, Deviation Resolution, Team Collaboration, Process Improvement, Record Review, Manufacturing Operations

Keywords

Quality Assurance, GMP Compliance, Manufacturing Batch Records, Analytical Testing, Biotech Manufacturing, cGMP Regulations, Electronic Systems, Documentation Compliance, Training, Problem Solving, Inspection Readiness, Deviation Resolution, Team Collaboration, Process Improvement, Record Review, Manufacturing Operations, Personal Protective Equipment, Clean Room Environment, Pharmaceutical Industry, Medical Device Industry, Batch Record Review, Return to Service Walkthroughs, Quality SOPs, Proactive Inspections, Audit Preparedness, Regulatory Requirements, Workplace Standards, Hazardous Chemicals, Inventory Management