The Specialist Quality Assurance provides oversight and leadership for quality systems execution while supporting complex manufacturing investigations and change controls
Job Summary
The Specialist Quality Assurance provides oversight and leadership for quality systems execution while supporting complex manufacturing investigations and change controls.
Candidates must have direct experience with bulk manufacturing of biopharmaceuticals or API within the pharmaceutical industry to ensure cGMP compliance.
Amgen offers vast opportunities for professional growth within a diverse and inclusive community that empowers teammates to bring ideas to the table.
Matching Summary
The Specialist Quality Assurance provides oversight and leadership for quality systems execution while supporting complex manufacturing investigations and change controls.
Skills & Requirements
Must-have
GMP compliance execution in plant operations
Complex root cause investigation leadership
Electronic batch record review expertise
Change control and CAPA system deployment
Regulatory audit and inspection participation
Nice-to-have
New Product Introduction team experience
Coaching site QA professionals
Continuous improvement project involvement
Supplier quality program knowledge
Strong technical writing and presentation skills
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 manufacturing or quality assurance
Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
Demonstrated proficiency in regulatory audits and inspections