Senior Associate Quality Assurance

Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, youll 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, youll 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 DoLets do this! Lets change the world!The Sr. Associate QA will be a member of the Amgen Thousand Oaks Clinical Final Drug Product QA team. Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. The Sr. Associate QA must be able to methodically and meticulously inspect printed materials for print quality defects, clinical product components (e.g. syringes and vials) for physical defects, and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities, such that the team members must be confident verbal communicators able to discuss responsibilities, divide them, reassess them, and potentially reassign them throughout the day or week. The Sr. Associate QA 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 IncludeInternal Quality Assurance support for Final Drug Product PackagingReview and approval of printed clinical labelsFinished clinical pack inspectionExpiration date calculationElectronic batch record reviewGMP Document (SOPs/FORMs) revision review/approval,Review and approval of electronic Maintenance documentation Work Order/Job Plans.Quality support and approval of minor deviations,Electronic Batch Record (MES) documentation revisions and approval.Quality support and approval of minor deviationsInternal Quality Assurance support for creation and revision of GMP procedures including document review, approval, and archivalGeneration and compilation of quality data and reports (e.g. lot track/trace, deviations). Individual will also assist with procedure reviews and initiation of deviation reports.Alerts management of significant quality, compliance, supply, and safety risksParticipates as a QA team member process during regulatory inspections, third party audits, and internal auditsThe successful candidate will have experience working in multiple GMP databasesWhat We Expect Of YouWe 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 QualificationsMaster's Degree ORBachelor's Degree & 6 months of cGMP experience ORAssociate's degree & 2 years of cGMP experience ORHigh school diploma/GED & 4 years of cGMP experiencePreferred QualificationsQuality and Manufacturing experience in biotech or Pharmaceutical industryBachelors Degree in Science fieldFamiliarity with basic project management toolsAbility to successfully manage workload to timelinesPrevious experience with quality system transactions (SAP, SM-LIMS, Trackwise, VeevaVault)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.Proficient with database use, including data input, archival, and query retrievalStrong 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, well support your journey every step of the way.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.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 IncludeA 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.SponsorshipSponsorship for this role is not guaranteed.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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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.