Quality Assurance Associate

Job not on LinkedIn

🔥 0 minutes ago

🐎 Kentucky, North Carolina – Remote

🐎 Kentucky – Remote 🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Assist Auditors with Sponsor audits and regulatory authority inspections • Manage and initiate regional testing for the annual update of the Business Continuity Plan • Assist in tracking audit findings, deviations and CAPAs identified in Quality Assurance Audits • Perform quality control of Standard Operating Procedures (SOPs), including formatting and spelling checks • Manage distribution of company SOPs • Recommend and implement process changes to improve use of the LMS • Create and format document templates and trackers • Maintain quality records per SOPs • Work with Auditors to learn and enhance Quality Assurance responsibilities • Assist with audit schedules and tracking deliverables • Assist QA Auditors with Vendor Audits, Internal System Audits and Computerized Systems validation • Assist in coordination of QMS activities, including co-administration, quality control documentation review, and user acceptance testing documentation • Assist with creating QMS procedures and work instructions/job aids • Assist QMS document owners/users with data entry into the QMS • Assist management with follow-up of deviations and CAPAs in the QMS • Assist with completion of RFIs related to Quality Management Systems international region-specific functions

🎯 Requirements

• Bachelor’s Degree or equivalent combination of education and experience • 0-1 years of work experience • Basic understanding of GxP Guidelines, namely ICH/GCP Guidelines and relevant country specific regulations • Excellent verbal and written communication skills

🏖️ Benefits

• Structured mentoring program and leadership courses • Tuition reimbursement • Dedicated training department • Generous health benefits • Vacation packages • Hybrid work from home opportunities • Paid parental leave • CTI Cares program • Work-life balance support