Principal Specialist, Quality Assurance (2nd Shift)
Core
Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Role type
Principal Specialist, Quality Assurance
Builds
Reliable, safe, and effective pharmaceutical products and services
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, quality inspection, sampling, training development, root cause analysis, regulatory documentation, corrective action planning, raw material review, visual inspection
Preferred skills
Advanced degree, 4-8 years experience, mentorship
Technologies
GMP, GDP, FDA regulations, EU regulations
Responsibilities
Inspect and sample products throughout the manufacturing process; Establish and maintain quality control procedures; 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
Senior, hands-on IC
