CSV Quality Assurance Engineer

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏱ Part Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 15%

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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Genovice

WebsiteLinkedInAll Job Openings

1 - 10 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Genovice is a dedicated staffing agency specializing in the Life Sciences and Healthcare Technology industries. Founded by industry experts, Genovice focuses on connecting companies with highly skilled professionals who meet both technical and cultural needs in fields such as biotechnology, pharmaceuticals, and healthcare technology. With a commitment to quality placements and a personalized approach, the agency ensures candidates not only meet technical qualifications but also align with company values and goals, making them a trusted partner in staffing solutions.

📋 Description

• Lead the development and continued improvement of the company’s quality management system • Conduct a QMS gap assessment and establish a risk-based implementation roadmap • Author, review, approve, and maintain quality policies, SOPs, work instructions, templates, and controlled records • Establish processes for document and record control, change control, deviations and nonconformances, CAPA, risk management, training, supplier qualification and monitoring, internal audits, management review, periodic system review, and quality review of product releases • Monitor adherence to approved quality procedures and follow up on identified gaps • Establish quality metrics and report risks, trends, and open actions to leadership • Ensure the quality system remains practical, scalable, and suitable for a growing technology organization • Establish company policies and standards for computerized system validation • Provide independent Quality oversight of validation activities performed by Engineering, Product, suppliers, customers, or other validation resources • Review and approve validation plans, intended-use statements, requirements, risk assessments, traceability matrices, test strategies, protocols, deviations, and validation summary reports • Confirm validation scope and evidence are appropriate for system intended use, complexity, and risk • Verify requirements are clear, testable, approved, and traceable to suitable evidence • Assess whether engineering and supplier testing can be leveraged as validation evidence • Identify circumstances requiring additional verification or independent Quality review • Review validation deviations and ensure they are investigated, documented, resolved, and approved • Confirm controls for audit trails, electronic signatures, user access, security, backup, recovery, data retention, and archiving meet applicable expectations • Ensure systems remain in a validated state through controlled changes, periodic reviews, and documented risk assessments • Provide Quality approval for validation completion and regulated product releases • Escalate material quality, compliance, and data-integrity risks to leadership • Prepare the organization for customer audits, supplier assessments, and regulatory inspections • Maintain organized, complete, and inspection-ready quality records • Support customer questionnaires, quality agreements, validation requests, and due-diligence reviews • Represent Quality during customer audits and explain the company’s QMS and validation-governance approach • Coordinate responses to audit observations and oversee corrective actions through closure • Review suppliers that could affect product quality, data integrity, regulatory compliance, or the validated state • Maintain Quality independence while partnering with Engineering, Product, Operations, and leadership

🎯 Requirements

• At least 7 years of Quality experience in pharmaceutical, biotechnology, life-sciences technology, or another highly regulated environment • Demonstrated experience developing, implementing, or significantly improving a quality management system • Strong experience providing independent Quality oversight of computerized system validation • Clear understanding of the distinction between validation execution and Quality review, approval, and governance • Experience reviewing and approving validation plans, requirements, risk assessments, traceability matrices, test evidence, deviations, and summary reports • Strong working knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP expectations, GAMP 5, and ALCOA+ data-integrity principles • Experience with document control, change control, CAPA, deviations, training, supplier quality, internal audits, and management review • Experience assessing the adequacy and traceability of software-testing evidence without acting as the routine software tester • Experience supporting customer audits or regulatory inspections • Excellent technical writing, judgment, organization, and communication skills • Ability to work independently while maintaining effective partnerships across technical and business teams • Reliable availability for approximately 20 hours per week • Strongly preferred: experience building a fit-for-purpose QMS for a software, SaaS, IoT, laboratory technology, or life-sciences technology company • Strongly preferred: experience overseeing validation of systems combining software, hardware, edge devices, scientific instruments, and external integrations • Strongly preferred: familiarity with LIMS, MES, ELN, QMS, laboratory automation, or scientific instrument connectivity • Strongly preferred: experience with quality expectations in the United States, Europe, and Asia-Pacific • Strongly preferred: familiarity with Japan’s PMDA and other Asia-Pacific authorities operating within or aligned with PIC/S frameworks • Strongly preferred: experience reviewing cloud infrastructure and third-party technology providers from a Quality and validation perspective • Strongly preferred: ability to introduce appropriate regulatory rigor without creating unnecessary bureaucracy

🏖️ Benefits

• Part-time commitment of approximately 20 hours per week • Remote work arrangement