Associate Specialist, Quality
Core
Provide direct shop floor support and quality oversight of packaging processes to ensure compliance with GMP and regulatory requirements for pharmaceutical manufacturing.
Role type
Associate Specialist, Quality (Manufacturing)
Builds
Compliant, reliable supply of pharmaceutical products to customers and patients
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP Compliance, Defect Resolution, Statistical Methods, Batch Record Review, Root Cause Analysis, Technical Writing, Inventory Control, 5S Organization, Regulatory Interpretation, Shift Work Adaptability
Preferred skills
Bachelor's degree in science, Pharmaceutical industry experience, Aseptic Manufacturing knowledge
Technologies
Inventory Management Systems, Laboratory Instrumentation
Responsibilities
Provide direct shop floor support including counts and material tagging; Evaluate defect resolution and control of material throughout the plant; Perform batch record review activities; Participate in plant investigation root cause analysis; Provide Quality Assurance review and approval of GMP-related SOPs; Maintain 5S organization and identify improvement opportunities.
Seniority
Associate, hands-on IC
