Sr Associate, Manufacturing (Technical Authoring/Deviation Investigations))

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Sr Associate, Manufacturing (Technical Authoring/Deviation Investigations) What you will do Let’s do this. Let’s change the world. In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process. Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for manufacturing team. Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents. Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner. Collaborate with multiple departments to support new/revise training documentation for manufacturing staff. Support process owners and participate in continuous process improvement and / or troubleshooting projects. Support manufacturing team in reducing document turnaround times. Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date. Develop protocols for Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs. Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA, complaints, and change control records. Track pending activities required to support change control implementations. Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems. Share knowledge with members of the manufacturing team. What we expect of you We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications. Basic Qualifications: High school/GED + 4 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies. OR Associate’s + 2 years years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies. OR Bachelor’s + 6 months years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies. OR Master's Preferred Qualifications: Educational Background in Science and/or Engineering. Experience working in GMP pharma and/or biotechnology industry. Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing. Experience with device assembly and packaging of final product. Ability to translate highly technical information into easily understandable information for manufacturing operators. Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users’ understanding. Experience supporting deviations, investigations, CAPA’s and change controls. A fact-based problem solver with strong troubleshooting and problem-solving skills. Pro-active with the ability to prioritize work to meet benchmarks Good documentation and communication What you can expect of 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’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 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. 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. . Salary Range 86,048.05USD -116,417.95 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit and follow us on