QA Operations Compliance Specialist
Core
Ensuring products leaving the biologics department meet standards for marketed and investigational drug products, including aseptic process simulations and regulatory compliance.
Role type
QA Operations Compliance Specialist
Builds
Manufactured biologics products for end users and regulatory authorities
Domain
Biopharmaceuticals / GMP / Aseptic Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Science degree, GMP background, quality oversight, investigation leading, batch record review, manufacturing log review, SOP/JSTM/Risk Assessment review, raw material inspection, stability program support, quality log administration, manufacturing floor walkarounds, process improvement
Preferred skills
Ability to work under own initiative, meeting tight deadlines
Technologies
GMP, SOPs, JSTMs, Risk Assessments, Batch Records, Manufacturing Logs, Quality Logs
Responsibilities
Ensuring products meet standards for marketed and investigational drug products; Providing quality and compliance oversight to the Operations function; Leading or assisting in investigations arising from non-compliance; Reviewing completed Batch Records and Manufacturing Logs; Completing quality review of operations documentation; Performing Incoming Raw Material checks; Providing Stability Program Support; Administering Quality Logs; Leading daily walkarounds of manufacturing areas; Driving continuous improvements to simplify site processes.
Seniority
Mid-level, hands-on IC
