Quality Control Data & LIMS Specialist

Indianapolis, IN, US • Posted 8 hours ago • Updated 8 hours ago

Contract W2

On-site

Eliassen Group

Fitment

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Job Details

Skills

SAP BASIS
Life Insurance
Testing
Data Management
Reporting
Storage
Management
Test Methods
System Integration
Interface Design
Process Improvement
Data Loading
System Documentation
Documentation
Inspection
GMP
ELN
LIMS
Master Data Management
Lifecycle Management
Good Manufacturing Practice
Pharmaceutics
Data Integrity
Workflow
Technical Writing
Communication
Collaboration
Manufacturing
Quality Control
Enterprise Resource Planning
MES
Materials Management
Screening
Artificial Intelligence
Recruiting
Taxes
Insurance
Law
Management Consulting
Finance
Regulatory Compliance

Summary

Description:
Onsite in Indianaolis, IN

Our client seeks a QC Data and LIMS Specialist to support a new advanced therapies manufacturing site as it moves into operations. The role will manage QC data workflows, configure and maintain LIMS and ELN master data, and partner with QC, IT, and global quality to enable compliant, efficient laboratory operations. The specialist will drive template creation, integration support, and adherence to cGMP and ALCOA+ data integrity standards. The position reports to the Site Laboratory Systems Lead and the Director of QC.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $50.00 to $60.00/hr. w2

Responsibilities:

Manage and track QC laboratory data including sample results, Certificates of Analysis, Certificates of Testing, stability study data, reports, trending, and testing progress trackers.
Support deviation tracking and data management for QC and sample-related issues.
Assist with data compilation, review, and reporting to support QC operations.
Perform LIMS master data creation and verification for specifications, sampling plans, product variants, site collection points, and storage records.
Support non-terminal record monitoring in alignment with SOPs and ensure LIMS functionality aligns with intended use, compliance, and end-user needs.
Support ELN template creation, review, and approval workflows.
Manage ELN and LIMS master data including equipment, reagents, consumables, and test methods, and perform second-person verification of master data entries.
Partner with QC, IT, and global teams to support LIMS data build and system integration strategy.
Contribute to system interface design with ERP, MES, ELN, and CoA systems.
Identify and implement process improvements related to QC data workflows and systems.
Develop or revise data load worksheets, SOPs and laboratory system documentation, and laboratory methods and execution documentation.
Ensure adherence to cGMP and data integrity standards (ALCOA+), support change controls and deviations, and maintain inspection readiness.

Experience Requirements:

Experience in Quality Control laboratories within a GMP-regulated environment.
Hands-on experience as a data administrator, power user, or data steward for LIMS and/or ELN systems.
Experience with LIMS master data configuration and lifecycle management.
Understanding of cGMP requirements and regulatory compliance in pharmaceutical manufacturing.
Knowledge of data integrity principles (ALCOA+).
Experience supporting laboratory systems and end-user workflows.
Technical writing, communication, and cross-functional collaboration skills.
Experience in advanced therapies or gene therapy manufacturing/QC (preferred).
Familiarity with ERP systems, MES, other lab platforms such as MODA, and CoA generation systems (preferred).
Understanding of batch disposition, materials management, and laboratory specifications and methods (preferred).

Recruitment Transparency Notice

Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.

Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact .

About Eliassen Group:

Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: cxelisen
Position Id: a1WUQ000001RBgL2AW
Posted 8 hours ago

Company Info

About Eliassen Group

Eliassen Group is a leading strategic consulting company that provides business and IT services for our clients as they seek to transform and execute strategies that will drive exceptional outcomes. Leveraging over 30 years of success, we focus on professional services, talent solutions, and life sciences. Eliassen Group offers local community presence and deep networks. We are committed to positively impacting the lives of our employees, clients, consultants, and the communities in which we operate.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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