Sr. Quality Assurance Engineer
5 days ago
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.
Sr. Quality Assurance EngineerLive
What you will do
Lets do this. Lets change the world. In this vital role you will be accountable to provide Quality oversight of CPO method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to CPOQ CORE and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites.Responsibilities:
Co-develop training materials for stability method transfers with CPOEnsures activities are in line with budget and support evidence-based resource needsProvides Quality oversight to CPO activities and results (A)Quality approval of protocols and technical reports for method development (D)Provides advice to inform Quality Plan (A)Provides advice and expertise to inform development of technical training materials for method transfer (A)Oversight of protocols and requirements to outsource testing to labs (A)Approved method development, validation, and transfer reportsRobust change controls, CAPAs, and NCsSuccessful CPO method stewardship deliverablesMethod training materialsReports to manager CPOQ Core in Thousand Oaks.Key advisor to Core Technologies LeadAdvisor to Innovation and Development LeadsAdvisor to site quality organizationsAdvisor to Product Quality Leaders (PQLs)Collaborate with and/or provide advice to Regulatory to inform submissionsAlign with Attribute Sciences where similar networks or governances are establishedCollaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliersWinWhat 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 degreeOr Masters degree and 2 years of quality experienceOr Bachelors degree and 4 years of quality experienceOr Associates degree and 8 years of quality experienceOr High school diploma / GED and 10 years of quality experience Preferred Qualifications:10+ years of quality and manufacturing experience in biotech or pharmaceutical industryBachelors Degree in a Science FieldExperience in developing physical methods for combination productsFamiliarity with force measurement equipment, dimensional analysis, calibration, and lab GLPLeadership skills and the ability to coordinate multiple projects simultaneouslyFamiliar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025Ability to discern user requirements for input to method developmentAble to successfully manage workload to timelinesThriveWhat 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. deadlineExternal/Internal postings: Amgen 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. 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.-
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