Senior Associate Quality Assurance

Career Category

Quality

Job Description

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

The Incoming Quality Assurance (IQA) Associate position will provide support for the IQA team, which is part of the Lot Disposition group of the Quality Assurance function. The role will be based out of Amgen Singapore Manufacturing (ASM) or one of its partner 3rd Party Logistics Service Provider (LSP) and will work under the general supervision of the hiring manager.

The IQA team provides expertise in performing inspection, sampling and testing of incoming materials to meet Amgen specifications and ensure a constant supply of raw materials for ASM.  The team provides these crucial services to ensure only the highest quality raw materials are used to create products for our patients.

Main Responsibilities:

• Comply with safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
• Complete required assigned training prior to execution of required tasks
• Perform raw material inspection, sampling and rapid ID testing in accordance to written SOPs and Methods.
• Generate complete and accurate documentation using electronic or handwritten systems.
• Review records to ensure raw materials are tested and inspected according to specification and SOPs
• Perform business operations related to inspection/sampling/testing (i.e updating dashboards, relevant metrics, housekeeping, inventory management, audit support)
• Support site/network Continual Improvement initiatives
• Ensures facilities, equipment, materials and procedures comply with cGMP practices and other applicable regulations
• Alert management of quality, compliance, supply and safety risks in a timely manner
• Participate in raw material issues or deviations
• Conduct trouble shooting related to systems and operations
• Conduct OJT training for new hires
• Maintenance of IQA related equipment
• Disposition of material Lots
• Present as Subject Matter Expert (SME) during Audits and Regulatory Inspections
• Act as delegate to IQA Manager as required to support business needs
• Performs additional duties as specified by management

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 6 years of directly related experience OR
• High School Diploma / GED and 8 years of directly related experience
• 5 years of experience in regulated environment
• Experience and basic troubleshooting skills with laboratory and process equipment
• Experience with LIMS, SAP, TrackWise, Veeva
• Ability to understand, apply and evaluate basic chemistry
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
• Ability to organize work, handle multiple priorities and meet deadlines
• Detail oriented as well as flexible and adaptable to changing priorities and requirements
• Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based Training (CBT)
• Ability and willingness to work in support of operations, which may include the occasional overtime or weekend, as required.
• Ability to handle first tier problem solving that may involve cross functional interactions
• Pass eye exam (corrected or uncorrected) in order to be qualified to perform visual inspection of raw materials. Failing these disqualifies a staff member from performing essential activities for the role.
  • Color Vision: Normal via Ishihara testing methods.
  • Stereo Depth Perception: (corrected or uncorrected) Stereo Depth less than or equal to 100 Arc Seconds.
  • Near Vision: (corrected or uncorrected) of 20/20, both eyes together.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

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.

careers.amgen.com

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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