This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
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
Requirements:
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.
What we offer:
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