For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
NOTE: This position will sit On-Site in Memphis, TN
The Site Data Integrity (DI) Program Lead is responsible for ensuring the site operates under applicable regulatory policies and Charles River Laboratories corporate policies for documentation and data integrity to ensure consistency and continuity across all functional segments at the Charles River Laboratories Memphis site. The Data Integrity Program Lead is the site data integrity Subject Matter Expert and will be responsible to ensure adequate SOPs, processes and training and education for Data Integrity principles are in place and consistently implemented at the Memphis site for cGxP data, both in paper and/or electronic format. The Site DI Program Lead must exhibit ability to develop and sustain collaborative partnerships across all functions at the Memphis site to implement, mature, and sustain delivery to DI principles and requirements for all paper and electronic data.
- The Site DI Program Lead is the point person during regulatory inspections and internal and client audits for Data integrity and plays a major role to answer questions and demonstrate that necessary controls and required competencies are in place with respect to Data Integrity
- Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and lifecycle management of data storage, review, and archival.
- Facilitate holistic data integrity reviews by partnering with cross-functional groups and stakeholders to conduct end to end business process assessments. Communicates actions, compliance gaps, and commitments to respective areas including the Site Director of Quality and reports on health of the DI Program at Memphis at monthly Quality Management Review governance meetings.
- Assist in sourcing, assessing, and recommending instrumentation and equipment for purchase; meets with vendors to discuss software capabilities with respect to 21CFR Part 11 compliance
- Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices
- Creates and updates procedures and processes as necessary to ensure operation’s awareness of the importance of regulatory requirements and expectations
- Routinely evaluates regulatory inspection documents and updates site procedures accordingly
- Aids in establishing user requirements for equipment
- Establishes and leads a data integrity program and partners with internal auditing teams to ensure internal audits at the site are assessed for compliance to documentation and data integrity standards, practices, and procedures.
- Perform all other related duties as assigned
Job Qualifications
- Bachelor’s degree in a science related field preferred
- Minimum 7 years’ experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems
- Advanced knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Thorough understanding of data integrity review, 21CFR Part 11 requirements, instrumentation compliance
- Strong technical knowledge and experience writing and reviewing investigations within a Quality Management System (TrackWise, preferred)
- Experience must include proven knowledge of Data Integrity (DI) related risk assessments and identification of mitigation actions
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)
- Effective written, interpersonal, and presentation skills
- Ability to work on multiple projects simultaneously
The pay range for this position is $111,700 – $124,900. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
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职位搜索
了解 CRL、我们的文化以及我们为何开展我们的工作,同时寻找与您的兴趣和专业知识相匹配的职位。
申请
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注意:根据职位的不同,您可能需要在申请中包含简历。评估和申请审查
如果需要,请完成评估,以确定该职位是否适合您,反之亦然。招聘人员将根据职位要求审查您的简历和资格,并确定后续步骤。
注意:在此过程中的任何时候,您都可以登录您的个人资料以查看您的申请状态。面试
通过与多元化的面试官会面来参与我们的包容性面试流程,他们将提供有关公司、文化和您的角色的信息,同时还会向您提出问题以评估您的技能、兴趣和专业知识。这也是您提问的好时机。 注意:Charles River 根据我们的 DNA(关注、领导力、责任心和团队合作)利用基于技术和行为的方法来提问。请熟悉 DNA 并准备好将您的经历与它们联系起来。
工作机会和入职
通过电话或电子邮件从 Charles River 招聘人员或招聘经理处接收有竞争力的录用通知书。录用通知书将包括您的头衔、工资、地点和其他相关信息。
注意: 接受后,您将与招聘人员一起确认入职日期,并在入职之前收到需要以电子方式完成的文件。对于美国的职位,一旦您接受,您将需要进行就业前药物筛查并通过犯罪背景调查。特色职位
Charles River每时每刻都在发生重要的事情。这意味着您可以探索令人兴奋的新职业机会。今天就申请吧!
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每时每刻
在 Charles River,您将能够为令人难以置信的突破做出贡献,同时体验令人兴奋的成长和发展机会。
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UX/UI设计师
提倡以用户为中心的设计解决方案。跨多个平台、设备和渠道创造独特、一致、品牌化的数字体验。
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UX/UI 高级设计师
定义并推动 UX/UI 策略和交互设计(从头开始并扩大规模),以解决业务和用户问题。
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副总监
与高级 UX/IX 设计师和开发人员合作评估问题并制定解决方案。通过建立编码标准化和自动化流程来执行计划。
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数字数据推动总监
领导跨业务部门和技术团队的用户体验管理和运营团队。识别并定义适合用途的策略来整合最佳实践。
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UX/UI 设计高级总监
指导、培训和引导设计团队制定与研究见解、执行、持续集成和自动化部署相关的设计策略。
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动物护理技术员 I-IV
通过提供食物、水和清洁的环境来维持动物的健康。
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动物护理技术员 I-IV
提供专业护理以维护和监控我们的动物的健康和物理环境。
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兽医技术员
帮助监控、记录和分类所有实验动物健康病例。
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团队领导 / 主管
监督、培训、动员、授权和发展一支高效的团队。
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研究助理
根据学习计划指南协调和计划活动。
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实习生一级
根据设施和部门需求支持流程/程序改进。了解我们的公司环境,以促进跨职能部门的协作。
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实习生二级
完成综合部门项目,将一级实习生的指导作为专业发展的一部分。
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生物制造技术员 I-III
监督细胞产品的生产、配方和储存,同时确保符合 GMP、GDP 和无菌指南。
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生物制造主管/专家
保持对专用设备的深入了解,以便作为所需设备的主题专家来解决问题。
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临床兽医 I-III
负责提供专业的兽医服务并帮助管理动物群医疗保健的各个阶段。
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高级临床兽医
利用实验动物医学知识来优化动物研究方案的科学目标。
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首席兽医 / 副主任
进行兽医咨询,提出治疗建议,与研究主任沟通,并跟踪案件直至解决。
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实验动物医学主任
对涉及现场实验动物的所有动物护理和使用功能提供技术和专业监督。
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技术员 I-III
遵守动物处理、饲养和血液/尿液收集方面的标准操作程序和协议。
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技术员 IV-V
处理高级技术员的职责,包括麻醉、领导和专门样本收集。
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项目负责人(科学)
担任实验室的科学专家,负责工作人员进行的研究。
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团队领导者
监督团队活动并在成为团队主管的道路上获得领导技能。
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团队主管(团队领导者)
负责整体员工监督、员工发展和团队成功。
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财务分析师
帮助分析财务数据,提取/定义相关信息并解释数据。
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二级财务分析师
负责项目的分析、预测、预算、会计管理和报告。
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高级财务分析师
处理每周和每月的预测和年度预算编制。准备业务审查的财务和关键指标。
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财务经理
与业务合作,提高关键决策领域的标准。呈现动态的行业、竞争对手和经济环境。
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运营财务总监
支持所有业务维度,与设施各团队合作指导每周/每月的预测和年度预算准备。
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生物制造技术员 I
支持新型细胞产品的生产、配方和储存(包括 cGMP、GDP 和无菌处理)。
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生物制造技术员 II
执行新型细胞产品的生产、配方和储存方面的专门活动(包括 cGMP、GDP 和无菌处理)。
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生物制造技术员 III
在与客户互动的同时,帮助推进新型细胞产品(包括 cGMP、GDP 和无菌处理)的生产、配方和储存。
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生物制造主管 / 专家
保持对专用设备的深入了解,以便作为所需设备的主题专家来解决问题。
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生物制造主管
监督生物制造人员,确保遵守 cGMP、CRL 质量体系和生物制造流程文件。
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生物制造经理
领导新型细胞产品的启动和 cGMP 生产中的生物制造活动。安排和管理员工,确保安全、合规的工作环境。
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客户经理
通过多设施协调确保高质量的客户服务。及时、准确、全面地回应客户需求。
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业务发展总监
通过定位和拜访客户来建立牢固的关系和客户忠诚度,实现盈利性销售增长。
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高级业务发展总监
规划并执行基于区域的现场销售策略。通过有针对性的长期和短期客户计划推动增长。
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区域销售经理
管理北美安全评估销售区域的销售团队,以实现销售和利润目标。
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总监
与设施领导层合作,实现绩效目标、培养员工并实施继任计划。
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高级总监 / 总经理
领导多功能团队,确保综合运营。与高层领导合作制定计划、目标和政策。
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执行董事
领导一个全球性的、多学科的团队。制定短期和长期战略计划,以最大限度地实现增长和盈利能力。
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公司副总裁
为领导层和财务团队提供领导力、指导和建议。负责财务规划、指导和控制。
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支持您的福祉
您的奉献和热情为世界各地的人们带来了拯救生命的改变。我们致力于为您提供福利,提高您的生活质量。