Quality Specialist I

🔥 6 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🚫👨‍🎓 No degree required

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• Assist Quality Management in monitoring GCP regulatory compliance and quality in clinical trial operations • Schedule and organize internal and external LabConnect assessments by QRS or clients • Schedule and perform internal assessments, including computer systems validation, equipment calibration and validation review, audits, study set-up QC, inspections, investigations, and gap analyses • Perform risk-based remote assessments of LabConnect vendors • Update and maintain QRS key performance indicators and other metrics • Participate in maintaining the electronic Quality Management System (eQMS), including creating, reviewing, issuing, revising, and controlling quality documents • Advise project managers and operational management on quality and regulatory matters • Participate in root cause analyses and define corrective and preventive actions for nonconformances and quality issues • Track, trend, and monitor nonconformance reports, customer complaints, audit findings, and document change control • Organize, maintain, and archive electronic and hard-copy quality records • Compose routine correspondence for internal and external stakeholders • Coordinate meetings, prepare agendas and facilities, and transcribe meeting minutes • Perform other assigned duties

🎯 Requirements

• Bachelor’s degree (B.S./B.A.) preferred; and 1-2 years of related experience and/or training; or equivalent combination of education and experience • Excellent attention to detail, planning, and problem-solving skills • Excellent organizational and time management skills • Excellent listening and verbal comprehension skills for professional communication and audit readiness • Ability to make well-thought-out decisions and adapt to changing environments and requirements • Self-motivation and ability to work independently and collaboratively • Ability to adhere to established timelines, processes, and procedures • Ability to balance multiple projects with attention to detail • Ability to sit for prolonged periods and work on a computer • Ability to use computers, headphones, phones, video, email, and office equipment • Ability to lift, pull, and/or push up to 25 pounds

🏖️ Benefits

• Minimal travel requirements

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