Quality Control Data & LIMS Specialist
Indianaolis, IN
Category: Q&R
Industry: Life Sciences
Reference ID: JN -042026-106221
Date Posted: 03/31/2026
Shortcut: http://careers.eliassen.com/yLSB2d
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).
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 InfoSec@eliassen.com.
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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. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
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