2,636 Data Integrity jobs in the United States

• Participate on teams of internal resources in delivery of CSV projects.
• Author functional requirements specifications that are complete, accurate, and testable.
• Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments.
• Author Validation Plans and Validation Reports.
• Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices.
• Experience in validation at least two of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.
• Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.
• Working knowledge of software testing techniques and test case development best practices.
• Working knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.
• Working knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.

• AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.
• Minimum 2 years of experience in the field of Computer System Validation.
• Minimum 2 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.
• Execute validation and verification testing protocols and document results
• Author SOPs for User Operation, System Administration and Maintenance, Back-up/Recovery, and Audit Trail Review
• Prepare project status reports for clients and ProPharma management
• Extensive travel may be required at times.
• Other duties as assigned.

At Children's Wisconsin, we believe kids deserve the best. Through the generous support of our friends and partners in the community, our exceptional doctors, nurses and care providers achieve the impossible every day. Our foundation provides a guidebook for giving, and ensures careful stewardship of all gifts. Our foundation is staffed with experts who guide donors through the many ways to support the care we give to kids. We work every day to ensure their wishes are honored. We offer a wide variety of rewarding career opportunities and are seeking individuals dedicated to helping us achieve our vision of the healthiest kids in the country. If you want to work for an organization that makes a difference for children and families, and encourages you to be at your best every day, please apply today.

The Data Integrity Specialist is a crucial member of the Foundation's Operations team, responsible for ensuring the accuracy, consistency, and integrity of all gift and constituent data across systems. This role goes beyond transactional data entry by ensuring that all gift and biographical information is entered accurately, consistently, and in alignment with internal standards. By contributing to accurate data entry and maintenance, this role helps ensure the reliability of donor information used for acknowledgements, reports, and fundraising activities. It plays an important role in enabling trust, efficiency, and performance in a mission-driven environment. This position requires critical and strategic thinking, and a strong understanding of relational database structures. It plays a key role in maintaining the integrity of donor records, improving data governance practices, and enabling high-impact donor engagement and accurate reporting.

Requirements:

• Requires bachelor's degree in computer science OR formal course work in computer applications, programs and software OR equivalent knowledge in data management, nonprofit administration, or related fields.
• 3+ years of progressive experience in nonprofit data management, gift processing, or CRM database administration.
• Formal training in computer applications and donor database systems (Raiser's Edge preferred).
• Demonstrated expertise in auditing, analyzing, and reconciling data.
• Strong knowledge of data structures, logical reasoning, and relational databases.
• Proven track record of identifying and implementing process improvements.
• Strong written and verbal communication skills, meticulous attention to detail, and a high degree of accuracy.
• Experience handling sensitive and confidential donor information in a professional, ethical manner.
• Ability to work both independently and collaboratively in a high-performance, goal-driven environment.
• Experience in a healthcare or hospital foundation environment.
• Familiarity with digital gift platforms (e.g., PayPal, Children's Miracle Network) and automated bank uploads.
• Familiarity with ServiceNow, PaperSave, and other data tools.
• Demonstrated leadership in competencies including customer focus, action orientation, strategic thinking, and ambiguity management.

Children's Wisconsin is an equal opportunity / affirmative action employer. We are committed to creating a diverse and inclusive environment for all employees. We treat everyone with dignity, respect, and fairness. We do not discriminate against any person on the basis of race, color, religion, sex, gender, gender identity and/or expression, sexual orientation, national origin, age, disability, veteran status, or any other status or condition protected by the law.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Summary:

The Data Integrity Manager will be responsible for ensuring flawless data management and compliance across our Greenville site. This outstanding opportunity allows you to lead a multidisciplinary team, ensuring the highest standards of data integrity in both cultural and technical aspects. You will be instrumental in implementing and maintaining compliance with 21CFR Part 11 and Annex 11 regulations. Join us to make a significant impact on our operations and drive outstanding data integrity initiatives!

Key Job Responsibilities:

• Prepare and facilitate Site Governance Team meetings.

• Provide detailed metrics to site leadership using systems like TrackWise, Power BI, and other site management tools.

• Monitor equipment and instrumentation to ensure strict compliance with 21CFR Part 11, Annex 11, and other regulatory guidelines.

• Lead and support Data Integrity initiatives, proactively improving the site's data integrity culture.

• Coordinate and track the Data Integrity Remediation Plan, ensuring all commitments are successfully met.

• Develop and deliver Data Integrity awareness training.

• Build and maintain procedures aligned with data integrity regulations.

• Coordinate the DI Surveillance program to ensure compliance with documentation standards.

• Collaborate on multidisciplinary projects to meet customer, business, and regulatory requirements.

• Present DI Metrics to site leadership monthly.

• Approve DI-related deviations, CAPA, and change controls.

• Assist in data integrity risk assessments.

Job Scope:

• Engage in meetings with cross-functional groups to discuss data integrity.

• Ensure operations and laboratories align with regulatory requirements.

• Apply professional concepts to resolve technical issues and lead critical initiatives.

• Network with key contacts and the Global DI network.

• Lead and influence teams regarding financial, equipment, standards, and resource needs.

Qualifications:

Education:

• Bachelor's Degree required, preferably in Science, Engineering, or related fields

Experience:

• Minimum of 8 years of experience with a Bachelor's degree, or 6 years with an advanced degree, in quality and data integrity.

• Experience with TrackWise and training preferred.

• Project Management, Supervision, or Management experience required.

Knowledge, Skills, Abilities :

• Proven knowledge of cGMP and cGDP.

• Experience with 21CFR Part 11/Annex 11 compliance and TrackWise.

• Proficiency in Microsoft Office Suite.

• Strong written, interpersonal, and presentation skills.

• Ability to manage multiple projects simultaneously.

Physical Requirements:

• Ability to move about office locations and perform physical tasks as needed.

• Dexterity for typing and using a computer.

• Visual acuity for reading materials and operating equipment.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Implement, lead, and manage an effective GxP Data Governance Program. The role is responsible for ensuring compliance with all regulatory and AbbVie requirements related to data integrity across multiple departments. The data integrity lead will implement a site strategy in compliance with regulatory and AbbVie global expectations, align site initiatives, and participate on the global Data Integrity Center of Excellence. Responsibilities: Implement and maintain Data Integrity compliance activities across the end-to-end product lifecycle and various departments in alignment with relevant regulatory regulations and guidelines. Represent AbbVie as the Quality Assurance subject matter expert during internal and external regulatory inspections related to data integrity. Work with external and internal partners to ensure best in class practices for data integrity. Develop training material and lead training efforts with SMEs. Manage remediation efforts, utilizing QRM based principles to identify risk and establish appropriate prioritization. Provide adjunct oversight of data integrity compliance for software development and validation lifecycle activities associated with GxP computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and AbbVie business requirements. Identification and prioritization of business benefit/opportunity. Effectively manage and execute strategic business opportunities to improve business processes. Participate in the Data Integrity Center of Excellence and implement CoE initiatives, as required. Provide day to day oversight for the governance, management and coordination of activities related to Data Integrity. Keep current on data integrity compliance and incorporate changes to continuously improve practices and procedures. Qualifications Qualifications: Bachelor’s Degree required; preferably in Physical or Life Sciences, Pharmacy, or Engineering. 8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry. Must be familiar with use of electronic document management and laboratory information management. Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements. Strong communication Skills, both oral and written. Expert knowledge of US Code of Federal regulations and the EU regulations. Subject Matter Expertise on Data Integrity principles, computerized systems and compliance activities related to system validation. Excellent communication and influencing skills at all levels of the organization are required to influence diverse, ad hoc teams of SMEs. Demonstrated project management skills and ability to lead effective change management. Understanding of Software Quality Assurance and Validation principles. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr

Join to apply for the Data Integrity Lead role at Katalyst CRO 5 months ago Be among the first 25 applicants Join to apply for the Data Integrity Lead role at Katalyst CRO Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments. Prioritize gaps and risks and provide oversight to needed remediation activities. Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems. Managing and Facilitating Data Mapping initiatives for programs level processes. Providing Business Analyst skills and resources to projects across QA to facilitate requirements gathering, development of process/ data flow maps, and data integrity assessments. Authoring, reviewing, and approving work process documents (SOPs and Work Instructions). Generating and maintaining metrics for Quality Leadership Teams. Identifying and implementing continuous improvement opportunities. Leading oversight of electronic data integrity compliance guidance for Vertex GxP systems. Assessing emerging needs in the industry to identify technology/ skills gaps within the team. Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for Program activities and initiatives within the QISM scope. Responsibilities Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end-to-end business processes assessments. Prioritize gaps and risks and provide oversight to needed remediation activities. Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems. Managing and Facilitating Data Mapping initiatives for programs level processes. Providing Business Analyst skills and resources to projects across QA to facilitate requirements gathering, development of process/ data flow maps, and data integrity assessments. Authoring, reviewing, and approving work process documents (SOPs and Work Instructions). Generating and maintaining metrics for Quality Leadership Teams. Identifying and implementing continuous improvement opportunities. Leading oversight of electronic data integrity compliance guidance for Vertex GxP systems. Assessing emerging needs in the industry to identify technology/ skills gaps within the team. Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for Program activities and initiatives within the QISM scope. Requirements: Identifying and implementing continuous improvement opportunities. Leading oversight of electronic data integrity compliance guidance for Vertex GxP systems. Assessing emerging needs in the industry to identify technology/ skills gaps within the team. Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for Program activities and initiatives within the QISM scope. Computer system validation, Data integrity, Medical device 510K, Predicate rules, ECTD,21 CFR Part 11, 210, 211, 312, 314, 820 GXP,GMP, GDP, GLP, CAPA, Change control, Risk assessment, Data base, Trail master file, EPIC system validation, Enrollment 834, Claims 837, Qualitative & Quantitative Analysis, HL7, HIPPA, SOP, SQL, HTML,XML, EDI, Silk, Client Quality Center, IBM Lotus notes, Jira Confluence, Microsoft TFS, LIMS. Seniority level Seniority level Mid-Senior level Employment type Employment type Contract Job function Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Data Integrity Specialist jobs in Boston, MA . Associate Director, Regulatory Data Governance Lead Boston, MA $153,600.00-$41,340.00 2 weeks ago Data Quality Specialist, AGI Data Services - G T Quality Data Quality Specialist, AGI Data Services - G T Quality Quincy, MA 75,040.00- 129,480.00 9 hours ago Data Quality Specialist, AGI Data Services - G T Quality Somerville, MA 80,000.00- 110,000.00 1 day ago Data Quality Specialist, AGI Data Services - G T Quality Chief of Office / Assistance Chief of Staff Special Agent: Mathametics/Data Expertise Director of Data Strategy and Transformation Digital Content and Data Visualization Strategist Data Engagement Intern, Asian Community Fund 25-26 Soccer Unity Project Data & Evaluation VISTA Associate Director – DD&T Data Governance Lead Boston, MA $1 3,600.00- 241,340.00 6 days ago Corporate Counsel, Global Privacy and Data Protection FedNow Data Specialist, Fraud Prevention Staff Data Scientist, Research, Search Platforms Cambridge, MA 197,000.00- 291,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

• Reviews various internal and external computerized systems and reports to determine correct patient identifying information for Northwestern Medicine Master Patient Index MPI and CIS.
• Utilizes technical expertise to analyze system-related changes and participates in testing of various software modifications.
• Monitors the transcription vendors quality.
• Provides statistical reports and feedback to management and vendor.
• Monitors report creation, electronic transfer and dissemination, updates systems accordingly to assure patient care data integrity.
• Supports high customer standards by responding to offsite vendors, internal customers and physician inquiries for patient information.
• Maintains several system databases for user IDs, passwords, access rights, and template revisions; Maintains CIS data integrity by flagging In error patient results.
• Provides system training for physicians, both attending and house staff.

• Minimum of 2 years experience in a hospital or medical office environment focusing on customer service, medical billing, data abstraction, and transcription.
• Demonstration of medical terminology knowledge.
• Strong customer service skills with heavy attention to detail.
• Oral, written and open communication skills along with analytical, leadership, organization, planning and time management skills.
• Strong Epic skills, and computer experience with Microsoft applications.
• Demonstrated ability to multitask.
• Demonstrates critical thinking skills.

• Bachelors degree or RHIT/RHIA credentials.
• Strong systems support experience.

The Data Integrity Manager will be responsible for ensuring flawless data management and compliance across our Greenville site. This outstanding opportunity allows you to lead a multidisciplinary team, ensuring the highest standards of data integrity in both cultural and technical aspects. You will be instrumental in implementing and maintaining compliance with 21CFR Part 11 and Annex 11 regulations. Join us to make a significant impact on our operations and drive outstanding data integrity initiatives!

• Prepare and facilitate Site Governance Team meetings.
• Provide detailed metrics to site leadership using systems like TrackWise, Power BI, and other site management tools.
• Monitor equipment and instrumentation to ensure strict compliance with 21CFR Part 11, Annex 11, and other regulatory guidelines.
• Lead and support Data Integrity initiatives, proactively improving the site's data integrity culture.
• Coordinate and track the Data Integrity Remediation Plan, ensuring all commitments are successfully met.
• Develop and deliver Data Integrity awareness training.
• Build and maintain procedures aligned with data integrity regulations.
• Coordinate the DI Surveillance program to ensure compliance with documentation standards.
• Collaborate on multidisciplinary projects to meet customer, business, and regulatory requirements.
• Present DI Metrics to site leadership monthly.
• Approve DI-related deviations, CAPA, and change controls.
• Assist in data integrity risk assessments.

• Engage in meetings with cross-functional groups to discuss data integrity.
• Ensure operations and laboratories align with regulatory requirements.
• Apply professional concepts to resolve technical issues and lead critical initiatives.
• Network with key contacts and the Global DI network.
• Lead and influence teams regarding financial, equipment, standards, and resource needs.

Education:

• Bachelor's Degree required, preferably in Science, Engineering, or related fields

Experience:

• Minimum of 8 years of experience with a Bachelor's degree, or 6 years with an advanced degree, in quality and data integrity.
• Experience with TrackWise and training preferred.
• Project Management, Supervision, or Management experience required.

Knowledge, Skills, Abilities:

• Proven knowledge of cGMP and cGDP.
• Experience with 21CFR Part 11/Annex 11 compliance and TrackWise.
• Proficiency in Microsoft Office Suite.
• Strong written, interpersonal, and presentation skills.
• Ability to manage multiple projects simultaneously.

Physical Requirements:

• Ability to move about office locations and perform physical tasks as needed.
• Dexterity for typing and using a computer.
• Visual acuity for reading materials and operating equipment.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!

Get AI-powered advice on this job and more exclusive features. Callahan & Associates, Inc. provided pay range This range is provided by Callahan & Associates, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $70,000.00/yr - $0,000.00/yr Additional compensation types Annual Bonus Direct message the job poster from Callahan & Associates, Inc. At Callahan & Associates, our people are at the heart of who we are. As a company, we empower credit unions to impact their members and communities. For more than thirty years, our team has been at the leading edge of credit union issues and innovation through leading research, analytics, networking and consulting. If you are looking to be part of a fast-paced, 100% employee-owned company that loves the industry we serve, encourages creativity, and rewards excellence – keep reading. Five Reasons Why You Want to Work With Us You want to work with a team that is competent, passionate and focused on achieving big goals. You want to work on products and deliver services that have the potential to help millions of people. You want to have a voice and employee ownership. You want to be part of a fun and healthy work culture. You want to work at a company that will provide an opportunity to get you to the next level of your career. Summary/Objective The Data Integrity Analyst is a highly analytical and detail-oriented role responsible for managing, validating and transforming critical business data. This position requires strong technical skills in SQL Server and SSIS, along with the ability to analyze complex data patterns, identify the root causes of inconsistencies and propose logical, effective solutions. The analyst must demonstrate sound critical thinking and a methodical approach to ensure the accuracy and reliability of key data assets. Key Responsibilities Assist in the implementation of the organization's data governance framework, including policies, procedures and data standards. Develop and maintain SQL queries, stored procedures and views to support data validation and quality monitoring. Build, manage, and optimize SSIS Packages for data extraction, transformation and loading (ETL) across multiple systems. Conduct regular data audits to detect anomalies, duplicates and integrity issues, and take corrective actions. Analyze data discrepancies to determine underlying causes and recommend process or system improvements. Collaborate with business users, developers and data stewards to define and enforce data quality standards. Document data flow processes, validation rules and quality metrics for reporting and compliance. Support projects involving data migration, integration or system upgrades with a focus on maintaining data integrity. Travel Minimal out-of-area and overnight travel is expected. Minimum Qualifications 5+ years of experience in a data-related role (e.g., data analyst, data quality analyst, business analyst). Proficient in Microsoft SQL Server (T-SQL, stored procedures, indexing, performance tuning). Experience with SQL Server Integration Services (SSIS) for ETL design and automation. Demonstrated ability to analyze and interpret complex datasets with a critical and logical approach. Demonstrated ability to troubleshoot issues and fix them. Solid understanding of data integrity principles and best practices. Familiarity with relational databases, data modeling, and normalization techniques. Comfortable working independently and collaboratively in a fast-paced environment. Excellent written and verbal communication skills. Preferred Qualifications Bachelor’s degree in Data Management, Information Systems, Computer Science, Business, or a related field. Familiarity with data governance tools such as Collibra, Informatica Axon, or Alation. Experience with Salesforce Experience with data governance or master data management (MDM). Background in industries with regulatory or high-accuracy data requirements (e.g., finance, healthcare). Seniority level Seniority level Associate Employment type Employment type Full-time Job function Job function Analyst Referrals increase your chances of interviewing at Callahan & Associates, Inc. by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave Tuition assistance Disability insurance Get notified about new Data Integrity Analyst jobs in Washington DC-Baltimore Area . 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Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr