Not specified; not specified; generous total rewar...
Gmp compliance requirements execution
Complex manufacturing investigations support
Electronic batch records review
The Specialist Quality Assurance provides oversight for quality systems execution and supports complex manufacturing investigations in the pharmaceutical industry
Job Summary
The Specialist Quality Assurance provides oversight for quality systems execution and supports complex manufacturing investigations in the pharmaceutical industry.
Candidates must have direct experience with bulk manufacturing of biopharmaceuticals or API and demonstrate proficiency in regulatory audits and inspections.
Amgen offers vast opportunities to learn, a diverse community of belonging, and a generous total rewards plan comprising health and career benefits.
Matching Summary
The Specialist Quality Assurance provides oversight for quality systems execution and supports complex manufacturing investigations in the pharmaceutical industry.
Salary
Not specified; Not specified; Generous Total Rewards Plan comprising health, finance, work/life balance, and career benefits
Skills & Requirements
Must-have
GMP compliance requirements execution
Complex manufacturing investigations support
Electronic batch records review
Change control and CAPA management
Regulatory inspection participation
Nice-to-have
New Product Introduction team experience
Continuous improvement project leadership
Supplier quality program knowledge
Effective technical communication skills
Diverse inclusive community collaboration
Key Requirements
Doctorate degree OR Master's + 2 years OR Bachelor's + 4 years OR Diploma + 8 years
8 years related work experience in pharmaceutical/biologics industry
Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
Demonstrated proficiency in written and verbal communication skills