质量合规助理
Associate Quality Compliance
### **职业类别**
质量
### **职位描述**
加入安进为患者服务的使命
在安进，如果你觉得自己是更大整体的一部分，那确实如此。我们共同的使命——为患有严重疾病患者服务——推动着我们所做的每一件事。
自1980年以来，我们在对抗世界上最难治愈的疾病中，帮助开创了生物技术的世界。我们专注于四个治疗领域——肿瘤学、炎症、普通医学和罕见病，每年惠及数百万患者。安进正在推进广泛的药物管线，用于治疗癌症、心脏病、炎症性疾病、罕见病和与肥胖相关的疾病。作为安进团队的一员，你将帮助对患者的生活产生持久影响，同时进行研究、生产和交付创新药物，帮助人们过上更长、更充实、更幸福的生活。
我们获奖的文化是协作、创新且以科学为基础的。如果你热衷于挑战以及其中的机会，你将在安进团队中茁壮成长。加入我们，改变患者的生命，同时改变你的职业生涯。
**质量合规专员**
**你将负责的工作**
让我们一起行动，改变世界。受控文档专员在通过执行和维护受控文档流程来支持安进研发质量管理系统方面发挥关键作用。该职位确保研发受控文档（如标准操作规程和工作指令）按照全球标准和GCP法规进行开发、维护和淘汰。该职位将跨部门协作，促进文档审批流程，进行质量检查，并支持检查准备活动。
**职责与要求：**
- 在受控文档管理系统（CDOCS）中执行并跟踪文档的创建、修订和作废流程。
- 为业务需求和项目提供受控文档影响分析。
- 在CDOCS中维护文档元数据。
- 对文档进行质量检查、编辑和校对，确保一致性和合规性。
- 监控文档流程，通知相关方待处理任务，并跟进以确保及时完成。
- 通过检索和整理所需文档，支持检查和审计。
**我们对你的期望**
我们每个人都不相同，但我们都用自己独特的贡献来为患者服务。这个岗位需要动态的思维和持续的学习能力。
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### **Career Category**
Quality
### **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-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 career.
**Associate Quality Compliance**
**What you will do**
Let’s do this. Let’s change the world. The Controlled Documentation Associate plays a critical role in supporting Amgen’s R&D Quality Management System through the execution and maintenance of controlled document workflows. This role ensures that R&D controlled documents, such as SOPs and work instructions, are developed, maintained, and retired in compliance with global standards and GCP regulations. The associate will collaborate across functions to facilitate document approval processes, conduct quality checks, and support inspection readiness activities.
**Roles & Responsibilities:**
- Execute and track workflows for creation, revision, and obsoletion of documents with the controlled document management system (CDOCS).
- Perform controlled document impact analysis in support of business requests and initiatives.
- Maintain document metadata in CDOCS.
- Conduct quality checks, editing, and proofreading of documents for consistency and compliance.
- Monitor document workflows, notify stakeholders of pending tasks, and follow up to ensure timely completion.
- Support inspections and audits by retrieving and compiling requested documents.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go getter with these qualifications
**Basic Qualifications:**
- High school/GED + 2 years of directly related experience OR
- Associate’s + 6 months directly related experience OR
- Bachelor’s
**Preferred Qualifications:**
- Strong attention to detail with proven ability to perform quality control reviews.
- Working knowledge of document control tools and best practices.
- Excellent verbal and written communication skills.
- Ability to manage document workflows and prioritize tasks.
**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.
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.
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**Salary Range**
USD - USD