Employment Type : Full-Time
Career CategoryQualityJob Description HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Specialist Quality Assurance – Drug Product What you will do Let’s do this. Let’s change the world! In this vital role through superior Quality oversight on-the-floor operations, you will be responsible for ensuring that pharmaceutical products are manufactured, tested, stored, and distributed according to cGMP practices and other applicable regulations. In addition, you will be responsible for ensuring facilities, equipment, materials, processes, and procedures adhere to cGMP and other regulatory requirements and remain in a state of inspection readiness. Specific responsibilities include but are not limited to: Provide on-the-floor support to Manufacturing operations and represent the Quality organization Perform review, audit, and approval of manufacturing batch records and protocols to ensure production records are complete, accurate, and documented according to written procedures and cGMP requirements Actively engage in Continuous Improvement initiatives, programs and projects and develop solutions that are thorough, practical and consistent with functional objectives Review and approve GMP documents and deviations as the Quality representative Certify that deviations from established procedures are investigated and documented per procedures Vigilantly ensure that changes that could potentially impact product quality are assessed according to procedures Apply analytical skills to evaluate and interpret complex situations and problems using multiple sources of information to anticipate and prevent potential problems Strongly collaborate and partner cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures Strategically advise to senior management of quality, compliance, supply and safety risks Support internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed Accountable for assigned training adherence to permit execution of applicable tasks Champion Continuous Improvement initiatives and projects Support multidisciplinary initiatives and projects as manager back-up when needed What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Specialist QA professional we seek is an Individual Contributor Leader with these qualifications. Doctorate degree Master’s degree & 3 years of Quality and/or Manufacturing support GMP regulated industry experience Bachelor’s degree & 5 years of Quality and/or Manufacturing support GMP regulated industry experience Educational background in Life Science, Engineering and/or Computer Science Experience in on-the-floor support to production and manufacturing operations Expertise in Quality Systems such as Non-Conformance, CAPA and Change Control Strong organizational skills, including ability to follow assignments through to completion Strong communications skills (oral and written) and comprehend in English and Spanish Enhanced skills in leading, influencing and negotiating Demonstrate ability to interact with regulatory agencies Solid word processing, presentation, database and spreadsheet application knowledge/skills Some of the vast rewards of working here As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor Objects in your future are closer than they appear. Join us: careers.amgen.com 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 a 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 an accommodation.
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