Master Data Specialist

Job Title: Master Data Specialist

Department: Global Product Development and Supply

Location: Summit, NJ

Job Type: Hybrid

Effective Date: 03/14/2025

Pay range: $50-$55 per hour

Work authorization:

Applicants must have the legal right to work in the United States without requiring sponsorship.

Corp-to-Corp (C2C) arrangements are not accepted.

JOB DESCRIPTION:

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

DUTIES AND 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 user.
• 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 process and improve efficiency. Collaborate with end users to develop business case.
• Anticipate mid- to long-term business needs and constraints. Support QC management in 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 to partner organizations (e.g., IT) for system solution.
• Facilitate design, testing and subsequent deployment of solutions.
• Support health agency inspection as equipment area subject matter expert.
• Perform other tasks as required to support the electronic systems.
• Must Have: Create, deploy, review, and sustain electronic systems Master Data.
• Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
• This position will report to QC management.

EDUCATION:

• Bachelor’s degree required, preferably in science or 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.

QUALIFICATIONS:

• 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, problem-solving skills and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers.
• Mentoring, coaching, influencing, negotiating and personnel interaction skills.

WORKING CONDITIONS:

• This role may involve working in an office, laboratory, or manufacturing area.
• Must be able to work in gowning attire within a controlled environment for extended periods.
• Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.
• Must be able to lift up to 15 pounds as needed.

ABOUT US:

SOKOL GxP Services is a rapidly expanding provider of Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), and a full suite of GxP services tailored to the pharmaceutical, biotechnology, cell therapy, and medical device industries. Our mission is to help clients achieve regulatory compliance while upholding the highest standards of product quality and safety.

Our customized solutions are designed to guide clients through complex regulatory landscapes, enhancing the efficiency and compliance of their GxP processes. At SOKOL, we’re committed to empowering our clients with the expertise and precision needed to confidently meet and exceed industry standards.

What We Offer:

Join SOKOL GxP Services! We partner with top pharmaceutical and biotech companies to deliver exceptional GxP and compliance services. At SOKOL, we’re dedicated to fostering diversity, supporting local talent, and building strong community connections to connect the best-qualified candidates with our clients. Be part of a dynamic team where you can shape the future of life sciences and advance your career in a collaborative, innovative environment. Our culture promotes growth and inclusivity, with a commitment to professional development and competitive benefits, including:

• Health benefits
• PTO
• Holiday pay
• Volunteer hours
• Relocation assistance*
• 401K** program
• Professional development opportunities
• Employee referral program

*Relocation support will be determined on a case-by-case basis.

**Our 401K program is set to launch in the 2025 fiscal year.

How to Apply:

https://www.sokolservices.com/open-positions

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.

By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.

Equal Opportunity Employer Statement:

SOKOL GxP Services is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law.