Senior Associate Quality Assurance - Thousand Oaks, CA

Job DescriptionATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Associate Quality AssuranceWhat you will doLet's do this! Let's change the world! Provide Quality Assurance oversight for 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 and inventory management.Typical tasks include:Internal Quality Assurance support for day to day GMP warehouse, dispensing, and inventory management operationsExternal Quality Assurance support for Logistics Service Provider problem reports, performance monitoring, temperature excursions, etc.Internal Quality Assurance support for Distribution functions in establishment and maintenance of specific product transportation lanes and modalitiesSupport investigations/deviation reports (Distribution temperature excursions and deviations)Internal Quality Assurance support for creation and revision of GMP procedures and record generation, including document review, approval, and archivalThe successful candidate will have experience working in multiple GMP databasesAdditional Qualifications/ResponsibilitiesWhat we expect of youWe 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:High school/GED + 4 years quality assurance work experience ORAssociate's + 2 years quality assurance work experience ORBachelor's + 6 months quality assurance work experienceMaster'sPreferred Qualifications:Previous experience in a Quality Assurance role supporting GMP operationsPrevious experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalentDemonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and adhering to good documentation practices.Educated in a science field with 2-3 years of experience in GMP/GCP operations or similarly regulated industryProficient with database use, including data input, archival, and query retrievalGreat attention to detail and high degree of accuracy in task execution and GMP documentationHighly effective verbal and written communication skills, strong interpersonal skillsAbility to complete tasks autonomously, provide updates to area manager, and identify potential issuesWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:A 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleSalary Range83,842.00 USD - 98,328.00 USD