Job title: Senior Associate QA
Company: Amgen
Job description: Career Category QualityJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.Duties include but are not limited to:Purposeful presence on the manufacturing floor, inc. Inspection support, ASP and QA assessmentsElectronic batch record reviewSOP revision approvalMaximo System – Work order, job plan approvalsQuality support and approval of minor deviationsMES revisions and approvalsProvide support for 24/5 ManufacturingResponsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is an employee with these qualifications.Basic Qualifications:High school diploma / GED and 4 years of Quality experience ORAssociate’s degree and 2 years of Quality experience ORBachelor’s degree and 6 months of Quality experience ORMaster’s degreePreferred Qualifications:Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science fieldDemonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practicesExperience managing projects through to completion meeting timelines.Ability to evaluate documentation and operations according to company procedures.Experience working with Quality SystemsStrong organizational skills and ability to manage multiple tasks at one timeEffective communication skills (both written and verbal)Demonstrated ability to work as both a team player and independentlyDisplay leadership attributes and drive improvement initiativesSolid understanding and application of aseptic behaviors and principlesWhat 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.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 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 possibleApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.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.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..Salary Range 83,842.00 USD – 98,328.00 USD
Expected salary: $83842 – 98328 per year
Location: Thousand Oaks, CA
Job date: Fri, 31 Jan 2025 06:32:06 GMT
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Senior Associate QA
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