QC Associate (Key User)
Core
Ensuring quality control laboratory compliance, managing digital systems, and leading equipment qualification and method validation in a pharmaceutical setting.
Role type
QC Associate (Key User) / Quality Control Laboratory Specialist
Builds
Qualified and validated QC laboratory equipment, compliant analytical methods, and digital system deployments for pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing / Quality Control / GxP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, data integrity, analytical method validation, equipment qualification, LIMS management, CAPA implementation, change control, deviation management, UAT execution, regulatory inspection support
Preferred skills
Experience with QC digital core models, stakeholder management, continuous improvement initiatives, technical system administration
Technologies
LIMS, computerized systems, QC digital tools
Responsibilities
Execute local deployments of QC digital solutions and issue related documentation; Maintain master data and provide training/support for end-users on QC tools; Lead compendial compliance assessments and periodic analytical method control trend reviews; Support qualification and maintenance of QC equipment and facilities; Investigate and resolve quality control events and discrepancies; Write and review protocols, UAT, and reports for analytical validation and transfers; Provide technical system administrator support for QC GXP laboratory computerized systems; Record raw data and calculations to comply with cGMP and data integrity requirements.
Seniority
Mid-level, hands-on IC
