Global Product Development and Supply - Master Data Specialist

Job Title: Master Data Specialist

Location: [Specify Location]
Work Schedule: Monday - Friday (Normal Business Hours)
Onsite Requirement: 50% Onsite

Must Haves:

• Create, deploy, review, and sustain electronic systems Master Data.
• Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.

Position Summary:

Responsible for the creation and execution of computer system validation documents as well as providing operational support and guidance related to system use and improvement.

Duties & Responsibilities:

• Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
• Provide electronic systems operational support and troubleshooting to end users.
• Create, deploy, review, and sustain electronic systems Master Data.
• Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
• Own project, CAPA, and deviation/investigation-related tasks and/or continuous improvement efforts.
• Propose and implement improvements to electronic systems to optimize business processes and improve efficiency.
• Collaborate with end users to develop business cases.
• Anticipate mid- to long-term business needs and constraints.
• Support QC management in the proposal and implementation of strategic initiatives.
• Anticipate and perform troubleshooting and problem-solving independently.
• Train and mentor others on electronic systems use and operation.
• Translate business requirements into technical design requirements and communicate with partner organizations (e.g., IT) for system solutions.
• Facilitate design, testing, and subsequent deployment of solutions.
• Support health agency inspections as an equipment area subject matter expert.
• Perform other tasks as required to support the electronic systems.

Reporting Relationship:

This position will report to QC management.

Qualifications:

Specific Knowledge, Skills, and Abilities:

• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Advanced technical and problem-solving skills with logical reasoning.
• Ability to communicate effectively with peers, department management, and cross-functional teams.
• Strong mentoring, coaching, influencing, negotiating, and personnel interaction skills.

Education, Experience, Licenses & Certifications:

• Bachelor's degree required, preferably in science or a related engineering field.
• 6+ years of relevant work experience in LIMS, ELN, and laboratory data analysis systems, preferably in a regulated environment.
• Knowledge of analytical and microbiological test methods and environmental monitoring programs preferred.
• Demonstrated technical writing skills.
• Demonstrated experience with validation and/or maintenance of laboratory information systems.