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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 Assurance

Senior Associate Quality Assurance
Job Description
Job Title: Senior Associate Quality Assurance (QA)
Requisition: 18570BR
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 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 QA will relocate to the United States for a 16-month training program before returning to work full time in the Singapore facility. Under general supervision, the QA Senior Associate will provide support and oversight to Manufacturing, Facilities and Engineering staff in regards to compliance and quality systems. They perform Batch Record review and closure, Standard Operating Procedure authoring, and review and approval of equipment use records, log books, analytical data, and work orders in support of Manufacturing or Engineering. The Senior Associate acts as Quality Assurance approver for nonconformance investigations and corrective and preventative action records. They review and approve validation protocols and reports; equipment, utilities, and computerized systems qualification documentation; and change control records. They provide quality oversight for in-process testing performed by manufacturing staff, including data and result review and unexpected result investigations. The Senior Associate also completes batch review and release for finished batches and/or raw materials; resolves issues with batch disposition processes including nonconformance investigations for raw materials; completes area internal audits; and participates in regulatory agency inspections and third-party audits of site quality systems.
Only candidates who apply via www.amgen.com/careers will be considered.
Please search the database via career category – College Job, requisition#18570BR.
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 Requirements:
§ 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 to make decisions independently in an environment that balances business need, quality and compliance risk
§ 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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