Quality Analyst

United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Trials, Healthcare TechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree, preferably in a Scientific or Technical Field, and have 2 to 5 years of experience in a Quality Assurance role within an FDA-regulated industry. Preferred qualifications include knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485, GDP, GCP, and experience with Quality Management Systems and CAPA. Exceptional written and verbal communication skills, attention to detail, proficiency in Excel, and the ability to work independently and in a team are essential.

Responsibilities

The Quality Analyst will manage Quality Events and CAPAs, serve as a resource for quality metrics and process improvement, and assist with the implementation and maintenance of Quality Management Systems. Responsibilities include managing Corrective Action and Preventive Action responses, conducting follow-ups to ensure timely completion of corrective actions, assisting with the development and distribution of KPIs and quality metrics, and creating documentation for new flows, procedures, and training materials. The role also involves assisting with updates to Standard Work Instructions and Standard Operating Procedures, managing multiple QA tasks, and prioritizing effectively to meet corporate quality objectives.

Skills

Quality Management Systems (QMS)

Corrective Action and Preventive Action (CAPA)

Key Performance Indicators (KPIs)

Standard Work Instructions

Standard Operating Procedures (SOPs)

Editing

Proofreading

Attention to detail

Written communication

Verbal communication

Time management

Prioritization

Clairo

Generates clinical evidence for trials

About Clairo

Clario specializes in generating clinical evidence for medical research by utilizing a comprehensive technology platform. Their services support various types of clinical trials, including decentralized, hybrid, and site-based trials. Clario's approach combines nearly 50 years of experience with a vast network of facilities across nine countries, allowing them to conduct a significant number of clinical trials and regulatory approvals. What sets Clario apart from competitors is their extensive expertise and the ability to provide a wide range of endpoint technologies, which enhances the quality of evidence produced. The company's goal is to empower partners in the healthcare industry to improve patient outcomes through reliable and rich clinical data.

London, United KingdomHeadquarters

1972Year Founded

$29.9MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

5,001-10,000Employees

Benefits

Competitive and equitable total rewards package

Physical, mental and financial health and wellness

Flexible working approach

Risks

Increased competition from AI-driven platforms like Medable may threaten Clario's market share.

The IPO filing may lead to investor pressure for rapid financial returns, affecting strategy.

AI integration from ArtiQ poses data privacy and compliance risks, especially in the EU.

Differentiation

Clario offers a comprehensive endpoint technology platform for diverse clinical trial models.

The company has nearly 50 years of experience in clinical trial technology solutions.

Clario's global presence includes 30 facilities across North America, Europe, and Asia Pacific.

Upsides

Clario's IPO aims for a valuation of over $10 billion, indicating strong market confidence.

The FDA clearance of SpiroSphere® with wireless ECG enhances Clario's clinical trial capabilities.

Clario's acquisition of ArtiQ boosts its AI capabilities in respiratory clinical trials.

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