QC Laboratory Data Systems Specialist, Pharma
Indianaolis, IN
Category: Q&R
Industry: Life Sciences
Reference ID: JN -042026-106611
Date Posted: 04/27/2026
Shortcut: http://careers.eliassen.com/vQbkYg
Description:
Onsite in Indianaolis, IN
Our client seeks a QC Laboratory Data Systems Specialist to support MODA, ELN, and SDMS at a new manufacturing facility operating under cGMP. The specialist will partner with QC SMEs to configure master data, develop ELN templates, and maintain compliant data lifecycle practices. The role will also drive reporting, support investigations and change controls, and collaborate with quality and IT stakeholders to improve system integration and workflows.
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: $60.00 to $70.00/hr. w2
#LI-JS1
JN -042026-106611
Responsibilities:
- Manage and support QC laboratory systems including MODA, ELN, and SDMS in a compliant cGMP environment.
- Ensure systems operate in alignment with regulatory and company requirements, including data integrity principles.
- Support sample and result tracking for environmental monitoring and utilities data.
- Create, maintain, and verify MODA master data including specifications, sampling plans, sampling sites, test methods, and LIMS interface data.
- Manage ELN master data for equipment, reagents, consumables, reference standards, and test methods.
- Perform second-person verification of master data entries.
- Design, build, review, and maintain ELN templates to enable paperless QC operations.
- Manage timelines for ELN template creation, review, and approval while ensuring workflow and compliance alignment.
- Create, compile, track, and review QC data and metadata including sample results, COAs, COTs, environmental monitoring reports, trending reports, testing trackers, and deviation and change control data.
- Contribute to SOP development and updates and support deviation investigations and change controls.
- Identify and implement process improvements for laboratory systems and workflows.
- Partner with global quality and IT teams to support system integration and data connectivity.
Experience Requirements:
- Experience in a Quality Control laboratory with strong knowledge of cGMP regulations and compliance requirements.
- Hands-on experience as a data administrator for laboratory systems.
- Experience with MODA data configuration and master data management.
- Experience with data integrity principles (ALCOA+).
- Familiarity with environmental monitoring and sterility assurance requirements such as EU GMP Annex 1.
- Experience with ELN systems as a power user or data steward.
- Strong technical writing, communication, and interpersonal skills.
- Experience in ATMP or gene therapy manufacturing or QC (preferred).
- Experience with ELN platforms such as NuGenesis and template configuration (preferred).
- Familiarity with laboratory instrumentation such as particle counters like Climet (preferred).
- Experience with equipment qualification, validation, and computer system validation (CSV) (preferred).
- Knowledge of system integration and data dependencies for MODA (preferred).
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.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
· Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@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.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contactInfoSec@eliassen.com.
Please ensure that you are working directly with us by confirming the following:
- When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
- Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group, as indicated above