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Amgen Inc

Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a d... Read More

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Senior Associate Quality Control

Senior Associate Quality Control
Job Description
Job Title: Senior Associate Quality Control (QC)
Requisition: 18571BR
Job/Project Description:
Amgen’s Quality department is looking for a Science or Engineering graduate student (graduating in Spring/Summer 2013) or an experienced hire for a full time position. The position will be with Amgen’s new Singapore facility; however, for the first 16 months of employment, the employee will participate in a comprehensive training program in two of Amgen’s U.S. facilities.
Amgen’s state-of-the-art biotechnology manufacturing and process development capabilities help us realize the potential of our pipeline for patients around the world. The new Amgen facility will be capable of manufacturing both clinical and commercial products.
The Senior Associate QC will relocate to the United States for a 16-month training program before returning to work full time in the Singapore facility. Under minimal supervision, the Senior Associate QC will be responsible for activities including analytical testing, method transfer, sample and data management and equipment maintenance. They will plan, perform and review multiple, complex routine/ non-routine methods and procedures and a large variety of assays. They will perform one or more of the following: sample testing, standards preparation and testing procedures, analysis for compendial and non-compendial test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance. Responsibilities will include data analysis and communication of results, writing protocols and performing assay validation and equipment qualification/ verification as well as maintaining and operating specialized equipment. The Senior Associate QC will comply with safety guidelines, cGMPs (Good Manufacturing Practices) and applicable regulatory requirements and will evaluate lab practices for compliance. They will introduce new techniques to the lab, provide technical guidance, and troubleshoot problems. They will also participate in investigations, audits, initiatives and projects that may be departmental or organizational in scope.
Only candidates who apply via www.amgen.com/careers will be considered.
Please search the database via career category – College Job, requisition#18571BR.
Amgen retains the right to add or change the duties of the position at any time.
As an EEO/AA M/F/V/D employer, Amgen values and encourages diversity in the workplace
§ Master’s degree in Science or Engineering (graduating no later than Summer 2013)
§ Undergraduate degree in Science or Engineering and 2 years of directly related experience
§ Undergraduate diploma in Science or Engineering and 6 years of directly related experience
§ 8 years of directly related experience
§ Must be eligible for US-based training program (Trainees must be Singapore Citizens or Permanent Residents)
Preferred Qualifications:
§ Fluency in written and spoken English (the US-based training program will be conducted in English)
§ 1 year of experience in regulated environment
§ Ability to understand, apply and evaluate basic chemistry, biology and physical principles
§ Regulatory knowledge
§ 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
§ Strong statistical mathematical skills
§ Ability to demonstrate project management skills
§ Demonstrated written and oral communication skills
§ Technical writing capabilities
§ Proficient presentation and facilitation skills
§ 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)
§ Mechanical ability/expertise
§ Strong analytical and experimental design skills
§ Capable of critical thinking and solving complex problems
§ Ability to independently collaborate with outside resources
§ Demonstrated ability to lead teams
§ Ability and willingness to work any shift in support of operations that may include 24/7

Other Job Information

Vacancy type:

Full Time

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