Quality Assurance Associate
Core
Provides real-time shop floor oversight and ensures product manufacturing conformance with quality system and regulatory requirements in a pharmaceutical/medical device environment.
Role type
Quality Assurance Associate (Manufacturing Operations)
Builds
Pharmaceutical and medical device products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance, Quality control, Batch record review, Manufacturing log review, Quality investigations, Cleanroom good practices, Contamination control strategy, EM data trend assessment
Preferred skills
Coaching and mentoring, GEMBA participation, Regulatory requirements knowledge
Technologies
None stated
Responsibilities
Review Batch Record documentation and Manufacturing logs, Support Quality investigations, Provide input to Site Contamination Control Strategy, Provide input to assessment of EM data and trends, Coach and mentor colleagues working in Cleanrooms, Participate in routine leadership GEMBAs of Manufacturing and Laboratory areas
Seniority
Mid-level, hands-on IC