SDO_Quality Assurance Specialist
Core
Ensures compliance with cGMP regulations and quality system requirements for packaging, labeling, and distribution operations through document control, training administration, and product release oversight.
Role type
Quality Assurance Specialist (Document Control/Training)
Builds
Compliant packaging and distribution processes for biopharma clients
Domain
Biopharmaceutical manufacturing and quality systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance knowledge, document control management, GMP training administration, product lot disposition, quality metric analysis, audit support, continuous improvement, data analysis (Access, Excel, Word), manufacturing process knowledge
Preferred skills
GMP and pharmaceutical standards knowledge, presentation skills, multitasking
Responsibilities
Perform product lot disposition by reviewing packaging records; execute document control activities in eQMS; coordinate and maintain site training programs; oversee new hire onboarding; deliver GMP training sessions; monitor training compliance metrics; collect and report quality metrics; maintain inspection readiness for audits; lead continuous improvement initiatives
Seniority
Individual Contributor, operational level