Clinical IT Quality Control Analyst - Remote US
通过加入麦克森子公司萨拉·坎农研究院 (SCRI) 的不断增长的团队，你将有机会成为全球最大的社区癌症项目之一的一部分，以推进瘤治疗和改善世界各地癌症患者的结果。我们寻找具有愿望推动抗癌斗争并改变每天被诊断患癌症患者的生活的人士。我们的使命与癌症生活的人员 那些努力预防，打击和生存者 是我们做出的每个决定的心脏。我们希望帮助你获得更多的支持。通过将最具创新性的医疗思想与社区中最热情的护理人员结合在一起，我们正在改变护理和个性化治疗。通过临床卓越和尖端研究，SCRI 在全球重新定义癌症护理.IT 质量控制专家监督软件，流程和数据完整验证过程的质量控制和保证。为萨拉卡农研究所内的运营团队提供指导和支持，以确保遵守 GxP,CFR 第21部分11项以及法规要求。密切有效地与全球质量和教育，IT QC 专家，验证专家，企业主，产品所有者和产品分析师合作。这是一个远程职位位于美国；迁移援助和签证赞助活动不存在。我们的 IT 质量控制专家负责：·提供支持研究运营和 IT 在软件验证，质量管理和 GxP 相关的公司和监管要求 （标准/政策/程序）的解释方面。并监督软件，流程和数据完整性验证有关的质量活动。· 通过准备，执行，数据分析和报告写作周期提供质量指导。· 根据定义的时间表协助系统文件定期审查，以确保继续遵守 SOP,公司政策，工作人员。· 支持 QI,OQ 和 PQ 协议的标准管理方案；
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.
McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: .
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Originally posted on Himalayas