Job Title
LIMS Data Verification Engineer
Company
Apex Systems
Location
Indianapolis, IN (On-Site)
Employment Type
Long Term Contract
Seniority Level
Mid-Senior level
Job Description
We are seeking a Master Data Verification Engineer to support a large Life Sciences client. This is a long-term contract with an immediate start date and requires on-site support three days a week.
Duties and Responsibilities
- Strong understanding of Test Methods, Parameter Lists, consumables type, and specification verification
- Verification of LIMS systems data and support of LIMS migrations
- Support implementation, maintenance, and monitoring of processes and procedures to ensure departmental compliance with relevant guidance and requirements
- Manage document and record control and archiving activities
- Manage training and competency programs
- Track, monitor, and present operational and quality metrics
- Initiate or support quality improvement initiatives to enhance performance and mitigate quality or compliance risks
- Support implementation of corrective actions resulting from audit observations and investigations
Minimum Education and Experience Required
Bachelor's degree in Life Sciences or equivalent with 3+ years of related experience in the healthcare industry3+ years of relevant experience in Quality Assurance, Auditing, and / or Verification in regulated industries—preferably pharmaceutical, biotech, or medical devicePreferred Qualifications
Experience with LIMS (Laboratory Information Management Systems) such as LabVantage, LabWare, STARLIMS, or similarWorking knowledge of accreditation standards, practices, and guidelines sufficient to guide laboratory operationsKnowledge of GCP / GCLP regulations, including 21 CFR Part 11Ability to comprehend regulations, guidance documents, and technical information related to equipment, processes, and regulatory expectationsStrong organizational skills for communicating with multidisciplinary project teamsFamiliarity with collecting and reporting quality metricsExperience with GMARS, SmartLab, and SmartSheetCapability to work independently with minimal supervision and to interact with staff in a fast-paced, pressure-filled environmentBenefits Overview
Apex Systems offers a comprehensive benefits package that includes medical, dental, vision, life, and disability insurance, an employee stock purchase program, a 401(k) plan with company match, a Health Savings Account, an employee assistance program, and extensive professional development resources.
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.
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