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Specialist QA

4 months ago

Thousand Oaks, California, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Quality AssuranceLive

What you will do

Lets do this. Lets change the world. Provide Quality Assurance oversight for global distribution and supply chain operations for commercial and clinical biopharmaceutical products. 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 like storage depots and transportation service providersTypical tasks include:

Internal Quality Assurance support for GMP warehouse and inventory management operations External Quality Assurance support for Logistics Service Provider problem reports, temperature excursions, facility changes, audit reports, etc. Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalities, including shipper qualification and management Support investigations/deviation reports (Distribution Temperature Excursions and Deviations) Assess incoming product lots for compliance to cold chain requirements Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archival The successful candidate will have experience working in multiple GMP databases WinWhat 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 individual with these qualifications. Basic Qualifications: Doctorate degree OR Masters degree and 2 years of quality assurance or operations experience OR Bachelors degree and 4 years of quality assurance or operations experience OR Associates degree and 8 years of quality assurance or operations experience OR High school diploma / GED and 10 years of quality assurance or operations experience Preferred Qualifications: 3+ years of experience in a Quality Assurance role supporting GMP operations Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva) 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. Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry Proficient with database use, including data input, archival, and query retrieval Great 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 ThriveWhat you can expect of us 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your 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.