Data Integrity Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ;br>
Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for Data Integrity Specialist to be in Titusville, NJ or Raritan, NJ.

The Data Integrity Specialist will provide technical expertise to ensure data is complete, consistent, accurate, trustworthy and reliable and these characteristics of the data are maintained throughout the data lifecycle. The Data Integrity Specialist will carry out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, DEA, OSHA, etc.) as well as all company and site policies and procedures. This role requires strong analytical and technical skills, with collaboration across departments and vendors to maintain high-quality data for reliable decision-making and regulatory compliance.

The Data Integrity Specialist is responsible for designing, implementing and maintaining a data control strategy for the Stability Operations Laboratory (supporting Titusville and Raritan, NJ sites); act as the Subject Matter Expert on Data Integrity processes including Good Documentation Practices and drive compliance efforts; support the equipment lifecycle management team during instrument qualification activities by participating in process flow mapping and data integrity assessments for all instruments and equipment; and ensure laboratory data handling and storage adhere to relevant policies and regulations.

The Data Integrity Specialist is accountable to manage and assure quality & compliance for lab equipment and instrumentation and ensure all regulatory commitments are met. They will act as a laboratory SME for data integrity issues that arise in the area of Equipment Lifecycle Management.

This role supports the New Jersey Stability Laboratory locations, therefore routine travel between Titusville and Raritan sites is expected.

Major Duties & Responsibilities

General:

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

Data Integrity Support 80%:

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.

Projects / Meetings 10%:

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

Quality & Compliance 10%

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

Other duties as assigned by management

Required Qualifications

Required Minimum Education: University / Bachelor's Degree

Minimum Required Years of Related Experience: 4-6 years

Required Knowledge, Skills and Abilities:

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)

Travel on the Job: Travel is expected to be split between Raritan and Titusville NJ sites.

Percentage Traveled: up to 10%

Type of Travel Required:

Domestic (US) International

Preferred Qualifications.

Preferred Minimum Education: University / Bachelor's Degree

Other: N/A

Preferred Area of Study: Science, Engineering, IT or Related

Preferred Related Industry Experience (if applicable):

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

Preferred Knowledge, Skills and Abilities:

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

Key Working Relationships

Internal

Frequent interaction with QC Analysts, peers in QC Lab Services, QC Supervisors and Managers and QC Stability Coordinators

Frequent interaction with Quality Assurance personnel

Frequent interaction with Global IT representatives, Maintenance and Facilities representatives, Environmental Health and Safety, and Global Quality Systems

Interaction with JSC Lab ELM COE members as needed

External

Contractors supporting the NJ Stability Operations (Equipment contractors, analysts, etc.)

Interaction with regulatory agencies during inspections

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy

The anticipated base pay range for this position is :
$79,000.00 - $127,650.00

Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o 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 o 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 Additional information can be found through the link below.