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LIMS Data Verification Engineer
LIMS Data Verification EngineerApex Systems • Indianapolis, IN, US
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LIMS Data Verification Engineer

LIMS Data Verification Engineer

Apex Systems • Indianapolis, IN, US
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Job Title

Master Data Verification Engineer

Location

Indianapolis, IN (On-Site)

Type

Long Term Contract

Job Description

Apex Systems, a global leader in Technology Services, is searching for Master Data Verification Engineers for a large Life Sciences client. This long-term contract has an immediate start date and requires data validation experience. The role requires on-site support three days a week due to the nature of the role.

Duties and Responsibilities

  • Strong understanding of Test Methods, Parameter Lists, consumables type, and specification verification.
  • Verification of LIMS systems data and supporting of LIMS migrations.
  • Supports the implementation, maintenance, and monitoring of processes and procedures to ensure departments are in compliance with relevant guidance and requirements.
  • Manage the document and record control and archiving activities.
  • Manage the training and competency program.
  • Supports the tracking, monitoring, and presentation of operational and quality metrics.
  • Initiates or supports quality improvements initiatives to enhance performance and / or mitigate quality or compliance risks, as needed.
  • Supports the implementation of corrective actions as a result of audit observations and investigations, as necessary.

Minimum Education and Experience Required

  • Bachelor's degree in Life Sciences or equivalent with 3+ years of related experience within the healthcare industry.
  • 3+ years relevant experience in areas of Quality Assurance, Auditing, and / or Verification, in regulated industries—preferably in Pharmaceutical, Biotech, Medical device.
  • Preferred Qualifications

  • Experience in LIMS (Laboratory Information Management Systems) such as LabVantage, LabWare, STARLIMS, or others.
  • Working knowledge of accreditation standards, practice, and guidelines sufficient to guide laboratory operations.
  • Knowledge of GCP / GCLP regulation including knowledge of 21 CFR Part 11.
  • Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
  • Strong organization to communicate to multi-disciplinary project teams.
  • Familiarity with collecting and reporting Quality Metrics.
  • Working experience with GMARS, SmartLab, and SmartSheet.
  • Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure-filled environment.
  • Apex Benefits Overview

    Apex Systems offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans. Additional benefits include an employee stock purchase program (ESPP), a 401(k) program with a company match after 12 months of tenure, a Health Savings Account (HSA) on the HDHP plan, and an Employee Assistance Program (EAP) with up to eight free counseling sessions. Professional development resources such as on-demand training, certification preparation, and a library of courses are available after six months of tenure.

    Equal Opportunity Employer

    Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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