QC Laboratory Data Systems Specialist, Pharma
Indianapolis, Delaware, United States of America
Contract
1 day ago
Key skills
AIArtificial IntelligenceCommunication
About this role
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 -11
Responsibilities:
Experience Requirements:
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 and hiring 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.
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 .
About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
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!
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 -11
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).
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 and hiring 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.
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 .
About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
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!