LIMS Data Verification Engineer

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Job#: 3026961

Job Description:

Role: Master Data Verification Engineer

Location: Indianapolis, IN (On-Site)

Type: Long Term Contract

Apex Systems, a global leader in Technology Services, is searching for Master Data Verification Engineers in Indianapolis, IN for a large Life Sciences client. This is a long-term contract with an immediate start date, and requires data validation experience. This role also requires on site support 3 days a week due to the nature of the role. See below for more details!

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 Google Cloud PlatformLP 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 Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6 months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.