Digital Operations, QC Specialist II

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $60k - $80k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Coordinate the global clinical study configuration QC process and manage study-level quality checks, including documentation, communication, risk identification, SOP compliance, and timeline adherence • Review finance CTMS, eSource, and other study configurations for protocol, budget, site network, and regulatory alignment • Identify, investigate, and resolve technical and configuration-related issues • Partner with study builders to understand build design and study requirements before QC activities • Collaborate with builders, customers, and stakeholders to resolve configuration questions and quality findings • Communicate study-level quality findings and coordinate resolutions with managers and collaborators • Identify opportunities to improve efficiency, quality, and processes, and help lead implementation • Partner across departments on client audits, CAPAs, and procedural documentation • Analyze moderately scoped problems and determine appropriate solutions using sound judgment • Present information to management and stakeholders while managing high-volume workloads and deadlines

🎯 Requirements

• Bachelor’s degree or equivalent relevant formal academic or vocational qualification • Previous technical QC or technical build experience comparable to 5 years • Experience working with ICH-GCP, FDA, and other applicable regulatory guidelines • Experience with medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentation preferred • In-depth knowledge of study configuration processes • Strong judgment, decision-making, analytical, and problem-solving abilities • Ability to work independently and adapt to rapidly changing priorities • Strong organization and time-management skills • Ability to use and learn software and systems for organizing information and producing reports • Continuous-improvement mindset and ability to identify efficiency and process improvements • Excellent attention to detail and commitment to quality • Demonstrated project management, communication, and organizational skills • Strong collaboration skills and positive, professional approach • Ability to manage a high-volume workload while meeting deadlines • Ability to present information confidently to management and stakeholders • Ability to apply professional concepts, company policies, and procedures to resolve issues • Ability to communicate, receive, and understand information with diverse groups of people • Ability to work upright and stationary during typical working hours • Ability to use and learn standard office equipment and technology proficiently • Ability to perform under pressure while prioritizing and handling multiple projects • Must be legally authorized to work in the United States without sponsorship • Must pass a comprehensive background check, including drug screening • May require as-needed travel of 0-20%

🏖️ Benefits

• Fully remote work arrangement • Variable annual bonus eligibility based on company, team, and/or individual performance results • As-needed travel may be required (0-20%) • Reasonable accommodation for individuals with disabilities during application, interview, and job functions • Benefits and privileges of employment