Drug Product Quality Assurance Specialist

Drug Product Quality Assurance Specialist At Amgen, we are committed to serving patients with serious illnesses by developing, manufacturing, and delivering innovative medicines. In the Thousand Oaks plant, the Drug Product QA Specialist provides quality oversight for aseptic drug product manufacturing and inspection areas. Under minimal supervision, you will ensure adherence to cGMP requirements, quality systems, and regulatory expectations while partnering with manufacturing, facilities, engineering, and quality control. Responsibilities Partners with manufacturing, facilities & engineering, quality control, and other cross‑functional stakeholders to facilitate root cause analyses, risk assessments, CAPAs, and effectiveness verification activities. Participates in and provides quality oversight for quality records including deviations, change controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations. Partners with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensure we continue to meet Amgen standards. Provides quality oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as non‑routine activities such as process and product validation. Provides quality expertise and guidance to operational staff and within cross‑functional Amgen teams. Reviews and approves controlled documents, including but not limited to standard operating procedures, protocols and reports. Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, safety, and controls. Participates in Amgen internal/external audits and inspections. Directly interacts with regulatory agencies during on‑site inspections. Contributes to and drives continuous improvement projects in cross‑functional collaboration. Represents the quality function and provides quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals. Contributes to and drives digital innovation solutions and applications in cross‑functional collaboration. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications. Basic Qualifications Doctorate degree OR Masters degree and 2 years of quality experience OR Bachelors degree and 4 years of quality experience OR Associates degree and 8 years of quality experience OR High school diploma / GED and 10 years of quality experience Preferred Qualifications Bachelors degree in science 5 plus years of aseptic processing experience in QA or manufacturing Strong experience supporting deviation investigations, root cause analysis, CAPA development, and quality management system processes such as change control and risk management Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners at all levels within the organization Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality‑minded conclusions Experience applying problem‑solving tools for root cause analysis. Experience participating in, managing, and responding to corporate audits/regulatory inspections Demonstrated ability with project management, initiating and leading cross‑functional teams, leading and managing change What You Can Expect From Us As 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 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 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 Flexible 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.com In 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 deadline: 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. Sponsorship: Sponsorship 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. 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. #J-18808-Ljbffr BioSpace