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
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
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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当您向我们申请工作时，您会非常小心和努力。请放心，我们将同样努力寻找适合您的职位。我们的招聘流程如下：
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
创建个人资料并申请您感兴趣的多个角色。
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。
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
创建个人资料并申请您感兴趣的多个角色。 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（关怀、领导、拥有和协作）利用基于技术和行为的面试问题。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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萨拉·霍塔奈宁，工商管理硕士
芬兰库奥皮奥
萨拉·霍塔奈宁，工商管理硕士
芬兰库奥皮奥
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