Sr. Associate Quality Assurance AML 14 - Night Shift

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Sr. Associate Quality Assurance AML 14 What you will do Let’s do this. Let’s change the world. In this vital role, you will be part of a department that provides 24/7 operational support through non-standard work schedules, including weekends and holidays. In this role you will ensure the integrity and compliance of materials and processes that support the delivery of high-quality, life-impacting products.  Specific responsibilities include but are not limited to: Responsible for providing on-site support to manufacturing areas and Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations Ensures that facilities, equipment, materials, organization, processes, procedures and products stay in sync with cGMP, cGLP practices, and other applicable regulations Actively engage in Continuous Improvement initiatives, programs and projects Ensures that changes that could potentially impact product quality are assessed according to procedures Ensures that deviations from established procedures are investigated and detailed per procedures Ensures that production records and testing results are complete, accurate, and detailed according to written procedures, cGMP, and cGLP requirements Participate in internal plant audits Assist in Investigations Perform sampling plans for all manufactured products, batch records review, SAP transactions, Trackwise system queries, deviations management and Veeva System queries Participate in triage process and Decision Making Process (DAI) Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies Work with operations to resolve basic compliance discrepancies What we expect of you   We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Quality Assurance professional we seek is an individual contributor with these qualifications.

High school/GED and 4 years of quality Assurance work experience  OR Associate’s and 2 years of quality Assurance work experience  OR Bachelor’s and 6 months of quality Assurance work experience  OR Master's Degree Preferred Qualifications: Educational background in Life Sciences or Engineering. GMP knowledge with ability to interpret and apply in routine cases. Experience with Trackwise, EBR, SAP, DQMS, LIMS systems and Veeva Systems. Strong technical writing and communication skills in English; bilingual (English/Spanish). Ability in problem-solving and providing solutions. Ability to evaluate documentation and operations per company guidelines. Intermediate proficiency in Word, Excel, PowerPoint, and database tools. Ability to work independently and collaboratively, prioritizing tasks and meeting deadlines. Basic understanding of statistical concepts and analytical