QC Scientist - Weekend Shift
Core
Perform microbiological testing for raw materials, in-process materials, drug substances, and products in a GMP-regulated pharmaceutical environment.
Role type
QC Scientist (Microbiology)
Builds
Supports product release, stability studies, and manufacturing operations
Domain
Pharmaceutical manufacturing / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Bioburden testing, Bacterial Endotoxin Testing (BET), GMP/GxP compliance, cGMP documentation, ALCOA+ data integrity, utility monitoring, method qualifications, validation support
Preferred skills
USP/EP/JP compendial methods, SAP/ERP/LIMS/ELN systems, CAPA/deviation/change control support
Technologies
SAP, ERP, LES, LIMS, WebStatistica, ELN, Veeva
Responsibilities
Perform routine and non-routine microbiological testing of raw materials, in-process samples, drug substance, drug product, and EM/UM samples; Execute Bioburden Testing and Bacterial Endotoxin Testing (BET) in accordance with approved procedures and compendial requirements; Collect, test, review, and trend utility monitoring samples from pharmaceutical water systems, clean steam, and compressed gas systems; Accurately document laboratory activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity principles; Support method qualifications, method transfers, equipment qualifications, and validation activities as assigned
Seniority
Mid-level, hands-on IC
