Associate Supervisor, Quality
Core
Oversee compliance for material movement, storage, reconciliation, segregation, quarantine, destruction, and issuance to production while ensuring finished goods meet customer requirements and cGMP regulations.
Role type
Administrative Quality Supervisor (Quality Assurance)
Builds
Quality documentation, protocols, and audit support for packaging and supply chain operations
Domain
Manufacturing / Packaging / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis (Quality documentation, protocols, audit support)
Required skills
cGMP regulatory knowledge, FDA regulations knowledge, Quality Management System (QMS) documentation, deviation management, change control management, nonconformance handling, validation management, internal audit facilitation, customer audit support, problem solving, delegation, technical writing
Preferred skills
Bachelor's degree, ASQ or other Quality certification, Bilingual Spanish
Technologies
MS Word, MS Excel
Responsibilities
Initiate and create Rework Protocols, Deviations, Change Controls, Nonconformances, and Validations; Review and approve Customer Requirements and Quality Department Job Descriptions; Support Quality Batch records, Quality Control Auditor, and Quality Material Release; Prepare for and support customer audits; Facilitate internal audit processes; Enter documentation into QMS; Initiate team meetings for special projects or process changes; Resolve significant Quality issues with Production and Quality Management.
Seniority
Mid-level, hands-on IC
