Johnson & Johnson

Makes prescription drugs and medical devices

Master Data Specialist 2

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeLeiden, NetherlandsNo salary listedHybrid

About the Job

Requirements

A bachelor's degree or equivalent in a relevant discipline is required.
Knowledge of laboratory systems and instrumentation.
Participation as a project team member.
Understanding of data integrity principles and compliance standards.
Experience with data analytics and statistical methods.
Strong communication skills for conveying complex information.
Ability to work collaboratively in a team-oriented environment.
Self-motivation, problem-solving skills, and the ability to manage multiple priorities.
For the 2–4 years experience tier: didactical skills for transferring information through training and procedures; experience in complex interdepartmental projects and troubleshooting; ability to serve as a subject matter expert during audits and inspections; self-direction in foundational and complex work.
For the 4–6 years experience tier: proficiency in Lean and Six Sigma methodologies.

Responsibilities

Maintain and manage master data, ensuring accuracy, consistency, and compliance with Good Manufacturing Practice standards.
Work with stakeholders to define data requirements and contribute to data governance initiatives.
Participate in projects and initiatives, providing input on implementation of new functionalities or enhancements based on business needs.
Create, review, and update documentation, including standard operating procedures and data management policies, ensuring clarity and compliance.
Lead data integrity assessments and implement master data management improvement initiatives.
Coordinate with departments to ensure data quality and support operational objectives.
Provide training and support to users on data-entry protocols, Laboratory Information Management System functionalities, and related processes.
Act as a liaison among laboratory staff, the Center of Excellence, information technology professionals, and management to optimize the use of the Laboratory Information Management System.
Stay informed about industry trends and best practices related to data management and Laboratory Information Management System technologies.
For the 2–4 years experience tier: manage local projects; lead continuous-improvement initiatives within the team; train and mentor team members in areas of expertise; act as the local site’s single point of contact for an expertise area.
For the 4–6 years experience tier: manage and lead complex projects; act as a globally recognized single point of contact for an expertise area.

Desired Qualifications

For the 0–2 years experience tier: 0–2 years of experience in data management or laboratory environments.
For the 2–4 years experience tier: 2–4 years of related work experience, preferably in a Laboratory Information Management System or laboratory context.
For the 4–6 years experience tier: 4–6 years of related work experience; advanced experience in Laboratory Information Management System data management projects.

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

Position overview

The Master Data Specialist is accountable for the management, integrity, and optimization of master data within QC, such as but not limited to the Laboratory Information Management System (LIMS). This role requires collaboration with various stakeholders to ensure data accuracy, accessibility, and compliance with regulatory standards, thereby supporting organizational goals and efficiency in laboratory operations.

Essential Job Duties and Responsibilities

Master Data Management: Maintain and manage master data, ensuring accuracy, consistency, and compliance with GMP standards.

Collaboration: Work with stakeholders to define data requirements and contribute to data governance initiatives.

Project Participation: Engage in projects and initiatives, providing input for the implementation of new functionalities or enhancements based on business needs.

Documentation: Create, review, and update relevant documentation, including SOPs and data management policies, ensuring clarity and compliance.

Continuous Improvement: Lead data integrity assessments and implement initiatives related to master data management.

Cross-Departmental Coordination: Collaborate with various departments to ensure data quality and support operational objectives.

Training and Support: Provide training and support to users regarding data entry protocols, LIMS functionalities, and associated processes.

Liaison Role: Act as a liaison between laboratory staff, Center of Excellence, IT professionals, and management to optimize the use of LIMS within the organization.

Industry Awareness: Stay informed of industry trends and best practices related to data management and LIMS technologies.

Competencies

Minimum Qualifications (Education/Experience)

Other Requirements

Bachelor’s degree (or equivalent) in a relevant discipline with 0-2 years of experience in data management or laboratory environments.

Knowledge of laboratory systems and instrumentation.
Participation as a Project team member.
Understanding of data integrity principles and compliance standards.
Experience with data analytics and statistical methods.
Strong communication skills for effectively conveying complex information.
Proven ability to work collaboratively in a team-oriented environment.
Self-motivated with robust problem-solving skills and the capacity to manage multiple priorities.

Bachelor’s degree (or equivalent) in a relevant discipline with 2-4 years of related working experience, preferably within a LIMS or laboratory context.

In addition to PG23 requirements

Didactical skills for effectively transferring information through training and procedures.
Management and leadership of local projects.
Experience in complex interdepartmental projects and troubleshooting.
Role as Subject Matter Expert during audits and inspections.
Self-directing in foundational and complex work.
Leadership in continuous improvement initiatives within the team.
Training and mentoring of other team members in areas of expertise.
Acts as a Single Point of Contact (SPOC) for expertise area for the local site

Bachelor’s degree (or equivalent) in a relevant discipline with 4-6 years of related working experience; advanced experience in LIMS data management projects is preferred.

In addition to PG24

Manages and lead complex projects.
Proficiency in Lean and Six Sigma methodologies.
Acts as a globally recognized Single Point of Contact (SPOC) for expertise.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size: 10,001+
Company stage: IPO
Headquarters: New Brunswick, NJ
Founded: 1886

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