Johnson & Johnson · 10 hours ago
Data Integrity Specialist
Raritan, New Jersey, United States of America
Full-time
Onsite
Mid Level
$79K/yr - $128K/yr
4+ years expJohnson & Johnson is a leader in healthcare innovation, committed to improving health for humanity. The Data Integrity Specialist will ensure the accuracy and reliability of data throughout its lifecycle while complying with regulations and company policies. This role involves collaboration across departments to maintain high-quality data for decision-making and regulatory compliance.
Hospital & Health Care
Responsibilities
Maintain data integrity standards for all lab equipment and instrumentation
Support system upgrades, maintenance, and roll-outs of new systems, as needed
Ensure accuracy, completeness and cGMP compliance in laboratory documentation as it pertains to Data Integrity
Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
Uphold our Credo values including creating a positive work environment
Train, develop, coach and mentor employees
Act as the Subject Matter Expert on Data Integrity including Good Documentation Practices, Good Manufacturing Practices and drive compliance efforts
Act as site Data Integrity SME, ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Enduring, Availability/Traceability) across the data lifecycle
Design, implement, and maintain a data control strategy for stability operations with responsibility for data classification, lineage, retention, archiving, and secure deletion per policy
Lead data integrity risk assessments and influence cross-functional teams on Data Integrity improvements
Maintenance and monitoring of Data Integrity at the Titusville and Raritan sites
Enable and empower Critical Thinking & Risk Management at Titusville and Raritan sites to ensure active risk management, taking all aspects of patients’ safety & product quality into account
Work closely with management to propose/complete improvement activities
Participate in the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications as it relates to Data Integrity
Contribute to Process Flow Mapping during instrument qualification and ensure documentation aligns with GAMP 5 and company policies
Participate in efforts to improve and update computer system compliance including providing guidance on the deployment and management of laboratory data management computer systems
Ensure data management and storage adhere to relevant policies and regulations
Represent the department in interdepartmental meetings in support of process improvement initiatives
Assess talent by participating in panel interviews for QC job candidates
Provide input to / lead functional laboratory meetings
Interface with Global Quality Systems and IT, as needed
Provide input and take actions as a QC Technical representative at cross-functional meetings
Engage with Data Integrity Specialist, Global Equipment Lifecycle Management CoE and ELM peers at other sites to leverage practices across the J&J Innovative Medicine Laboratory network
Support the development and execution of CREDO and Lean Lab action plans and initiatives
Support internal audits and Health Authority inspections as a local SME
Ensure compliance to J&J Innovative Medicine Quality global and local procedures, regulatory/ Health Authority requirements, and industry standards
Complete and approve corrective and preventative actions (CAPA) as assigned
Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and computer systems validation (e.g., GAMP 5, USP <1058>, 21 CFR Part 210/211 etc.)
Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements
Other duties as assigned by management
Qualification
Required
University / Bachelor's Degree
4-6 years of related experience
Strong knowledge of data integrity principles (ALCOA+)
Ability to work with others in a team environment
Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
Technical knowledge of computer system validation, instrument qualification (IQ/OQ/PQ), data management systems, Data lineage, Audit trails, and Regulatory documentation practices
Strong interpersonal and written/oral communication skills
Ability to quickly process complex information and often make critical decisions with limited information
Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities
Ability to independently manage a portfolio of ongoing projects
Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
Proficiency with using Microsoft Office applications (Outlook, Excel, Word, Project and PowerPoint)
Preferred
University / Bachelor's Degree
Preferred Area of Study: Science, Engineering, IT or Related
Experience in a regulated environment with IT/data systems (LIMS/ELM/ELN/CDS)
Demonstrated ability to influence peers and drive change
Training in data integrity concepts, ALCOA+, and regulatory horizon scanning
Creativity regarding basic problem solving and troubleshooting
The QC ELM Specialist shall have the capability to develop improvement ideas and independently implement associated solutions
Possesses the ability to positively influence peers, key stakeholders and management
Positive and optimistic with the ability to act as a pro-active change agent
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work
Personal and Family Time - up to 40 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase