Career Category

Job Description

Amgen Rhode Island is currently looking to hire a Senior Associate Quality Control. The position will operate on an administrative shift schedule.

Responsibilities:

• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Operate and maintain specialized laboratory equipment and instrumentation
• Participate in laboratory investigations and audits as necessary
• At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
• Performs review and approval of procedures, assays, documents and records
• Supports Continuous Improvement initiatives, programs and projects
• Alerts management of quality, compliance, supply and safety risks
• Supports internal/external audits and inspections
• Completes assigned training to permit execution of tasks
• Performs additional duties as specified by management

Basic Qualifications

• Master's Degree

OR

• Bachelor's Degree and 2 years of Quality experience

OR

• Associate's degree and 6 years of Quality experience

OR

• High school diploma/GED and 8 years of Quality experience

Preferred Qualifications

• 4 years experience in performing analytical methods in a regulated environment including HPLC/UPLC assays and UV.
• Demonstrated experience in investigations, validation, audits, and QC processes
• Demonstrated ability to interpret data and troubleshoot method issues
• Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
• Strong communication skills (both written and oral), facilitation and presentation skills
• GMP/GDP experience

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.