临床IT质量控制分析师 - 远程美国
Clinical IT Quality Control Analyst - Remote US
这不是一份工作，而是一份使命。
我们的员工是成功的基础。加入位于麦肯锡旗下Sarah Cannon Research Institute（SCRI）的不断壮大的团队，你将有机会成为全球最大的基于社区的癌症项目之一，推动肿瘤治疗的发展并改善全球癌症患者的结果。我们寻找有使命感的候选人，他们渴望推进对抗癌症的斗争，并每天为被诊断出癌症的患者带来改变。
我们的使命
患有癌症的人——那些努力预防、对抗和战胜癌症的人——是我们每个决策的核心。我们将最创新的医学人才与社区中最热情的护理人员结合在一起，正在改变医疗方式并实现个性化治疗。通过卓越的临床实践和前沿研究，SCRI正在重新定义全球的癌症护理。
IT质量控制专员负责软件、流程和数据完整性验证过程的质量控制和保证。为Sarah Cannon Research Institute内的运营团队提供指导和支持，以确保符合GxP、21 CFR Part 11和监管要求。与全球质量与教育、IT QC专员、验证专员、业务负责人、产品负责人和产品分析师紧密且有效地合作。
这是一个位于美国的远程职位；不提供搬迁补助和签证担保。
我们的IT质量控制专员负责以下工作：
- 为研究运营和IT提供支持，解释与软件验证、质量管理、GxP相关的公司和监管要求（标准/政策/程序），并监督与软件、流程和数据完整性验证相关的质量活动。
- 审查验证生命周期文档，包括验证评估、21 CFR Part 11评估、系统验证计划、风险管理计划和验证总结报告，遵循SOP、公司政策、标准和政府法规，以确保完整性和准确性。
- 在IQ、OQ和PQ协议的准备、执行、数据分析和报告撰写周期中提供质量指导支持。
- 按照规定的日程对系统文档进行定期审查，以确保持续符合SOP、公司政策、标准和法规。
查看英文原文
It’s More Than a Career, It’s a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
The IT Quality Control Specialist oversees quality control and assurance of software, process, and data integrity validation processes. Provides guidance and support to operational teams within Sarah Cannon Research Institute to ensure compliance with GxP, 21 CFR Part 11, and regulatory requirements. Works closely and effectively with Global Quality and Education, IT QC Specialists, Validation Specialists, Business Owners, Product Owners, and Product Analysts.
This is a remote position based in the US; relocation assistance and visa sponsorship are not available.
What our IT Quality Control Specialist is responsible for:
- Provides support to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversees quality activities related to software, process, and data integrity validation.
- Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy.
- Provides support of quality guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols.
- Assists with periodic review of system documentation according to defined schedule to ensure continued compliance with SOPs, corporate policies, standards, and government regulations.
- Provides quality review of related to changes that impact validated systems and/or processes.
- Other duties as assigned
Qualifications for success include:
- Bachelor's Degree required; professional qualified experience may be substituted for education.
- Direct experience in QA/QC role in computerized systems validation
- Experience in GCP clinical space, such as CRO or SMO, is highly preferred
- 3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines.
- Experience and knowledge of EU regulations, e.g., Annex 11 is preferred.
- Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc.
- Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles.
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
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Originally posted on Himalayas