Principal Specialist, Quality Assurance (2nd Shift)
Core
Develops and implements quality policies and procedures to ensure products and services comply with regulatory standards and specifications.
Role type
Principal Specialist, Quality Assurance
Builds
compliant and cost-effective quality system for manufacturing products
Domain
Healthcare manufacturing / Quality Assurance
Required skills
GMP compliance, inspection and sampling, quality control procedures, regulatory review (FDA/EU), corrective action implementation, training development, root cause analysis, documentation, visual inspection
Preferred skills
Advanced degree, 4-8 years experience, mentorship
Technologies
GMP, GDP, EHS, Radiation Safety
Responsibilities
Inspect and sample products throughout manufacturing; establish and maintain quality control procedures; interact with manufacturing to set quality standards for raw materials and finished goods; champion GMP and EHS practices; develop and lead GMP/GDP training; troubleshoot quality deficiencies and implement corrective measures; review and disposition incoming raw materials; approve minor quality events; assist in final product release compliance.
Seniority
Principal, hands-on IC with mentorship
