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Senior Associate Quality Assurance
3 weeks ago
Senior Associate Quality Assurance
Amgen Singapore Manufacturing
HOW MIGHT YOU DEFY IMAGINATION?
Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Associate Quality Assurance in Singapore.
Live
What you will do
Responsible for providing oversight for Quality on-the-floor and operations support, the Senior Associate Quality Assurance will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (day/night).
Main Responsibilities:
Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
Independently complete routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports, deviation records and validation protocols etc.) and ensure key performance indicator met targeted metrics
Support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
Act as Quality Assurance change control record assessor in change control activities and Quality Assurance contact for investigations.
Participate in regulatory inspections, and interact directly with regulatory inspectors
Coach site Quality Assurance professionals on resolution of routine operation issues
Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Win
What we expect of you
Basic Qualifications
Masters Degree OR
Bachelor's Degree and 2 years of directly related experience OR
Associate's Degree and 4 years of directly related experience OR
High School Diploma / GED and 6 years of directly related experience
Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry
Related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Good communication skills (technical writing and verbal communication/presentation) and the ability to collaborate with stakeholders
Interacts effectively with variety of communication and working styles
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality.
Strong decision-making skills and ability to explain rationale to others
Proactive in knowledge sharing with team members to help team enhance their skills
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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