Amgen Foundation, Inc

The QA Specialist will be a member of the Amgen Thousand Oaks (ATO) Warehouse and Distribution Quality Team. The QA Specialist will provide Quality Assurance oversight for warehouse and supply chain operations for commercial and clinical biopharmaceutical products.. The QA Specialist will ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers such as storage depots and transportation service providers.. The QA Specialist may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.. Internal Quality Assurance support for creation and revision of GMP procedures including document review, approval, and archival. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

distribution

**Specialist, QA Warehouse and Distribution** US , CA,Thousand Oaks **** ****Live**** **What you will do** Lets do this. Lets change the world. The QA Specialist will be a member of the Amgen Thousand Oaks (ATO) Warehouse and Distribution Quality Team. The QA Specialist will provide Quality Assurance oversight for warehouse and supply chain operations for commercial and clinical biopharmaceutical products. The QA Specialist will ensure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution, inventory management, and management of external relationships with Logistics Service Providers such as storage depots and transportation service providers. The QA Specialist may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment. **** ****Responsibilities include:**** * Internal Quality Assurance support for GMP warehouse and inventory management operations * Review and provide Quality approval for electronic and paper incoming material receipt records, and GMP documentation such as work orders, investigation reports, change control records, corrective action / preventive action records, and other GMP records * Internal Quality Assurance support for creation and revision of GMP procedures including document review, approval, and archival * Support investigations/deviation reports for warehouse operations and incoming materials * Assess incoming product lots for compliance to specification requirements * Manage QA product reserve sample inventory * Alerts management of significant quality, compliance, supply, and safety risks * Participates as a QA team member process during regulatory inspections, third party audits, and internal audits * Makes certain the Quality Management System processes are implemented in accordance with established procedures * The successful candidate will have experience working in multiple GMP databases **** ****Win**** **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications. **Basic Qualifications** * Doctorate Degree OR * Master's Degree & 3 years of cGMP experience OR * Bachelor's Degree & 5 years of cGMP experience OR * Associate's degree & 10 years of cGMP experience OR * High school diploma/GED & 12 years of cGMP experience **** ****Preferred Qualifications**** * 3+ years of experience in a Quality Assurance role supporting GMP operations * Previous experience with quality system transactions (SAP, SM-LIMS, Trackwise, VeevaVault) * Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent * Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices. * Proficient with database use, including data input, archival, and query retrieval * Strong attention to detail and high degree of accuracy in task execution and GMP documentation * Highly effective verbal and written communication skills, strong interpersonal skills * Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues **** ****Thrive**** **Some of the vast rewards of working here** As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. * Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey * A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act * Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. **** ****Apply now**** **for a career that defies imagination** Objects in your future are closer than they appear. Join us. ****careers.amgen.com**** Join Us If youre seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, youll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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 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 accommodation. Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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