Qa Specialist II- Validation
Core
QA Specialist supporting cGMP pharmaceutical/medical device contract manufacturing validation activities across multiple facilities.
Role type
Mid-level IC Quality Assurance Specialist (Validation)
Builds
Validated equipment, utilities, processes, and systems for biopharma clients
Domain
Biopharmaceutical contract manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, validation methodology, risk-based assessment, GMP system oversight, deviation/CAPA/change control review, batch record review, international quality regulations
Preferred skills
ASQ certification, thermal characterization, vacuum physics, heat and mass transfer, formulation, aseptic filling, lyophilization, steam sterilization, Part 11 compliance, software development life cycle principles
Technologies
Microsoft Word, Excel, Outlook, PPT
Responsibilities
Review and approve validation plans, URS, protocols, and summary reports; partner with cross-functional teams on validation projects; provide QA oversight for GMP validation activities; guide junior team members; participate in continuous improvement of Quality Systems
Seniority
Mid-level, hands-on IC with mentorship duties
