Data Integrity Specialist

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

4d•$79,000 - $127,650

About The Position

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. Learn more at https://www.jnj.com/innovative-medicine 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.

Requirements

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.

Nice To Haves

Preferred Minimum Education: 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

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

Benefits

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

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