Manager, Document Control

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Quva

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2015

💊 Pharmaceuticals

🤖 Artificial Intelligence

☁️ SaaS

Pharmaceuticals • Artificial Intelligence • SaaS

Quva is a combined pharmaceutical manufacturer and health-system pharmacy analytics company that produces high-quality, sterile ready-to-administer (RTA) injectable compounded medications and delivers AI-powered data and analytics solutions for hospitals and health systems. Quva Pharma operates 503B sterile outsourcing and forward distribution capabilities to supply thousands of U. S. hospitals, while Quva BrightStream (formerly LogicStream Health) provides a SaaS platform that ingests disparate clinical and operational data to deliver predictive insights and tools such as shortage navigation, diversion surveillance, supply optimization, revenue capture, contract compliance, and clinical process optimization. The company emphasizes quality, regulatory-compliant manufacturing, distribution reliability, and data-driven solutions to improve pharmacy operations, reduce shortages and errors, and drive better patient and financial outcomes.

📋 Description

• Accountable & responsible for creation and revisions of SOPs, WIs, Policies, and other Quva documents in compliance with cGMP regulations • Accountable & Responsible for Document Change Requests (DCR) • Accountable & Responsible for DCR Creator/Revisor Instructor Lead Training (ILT) • Supports training activities for batch record/logbook issuance & archiving • Accountable for batch record and logbook issuance and archiving • Assures compliance with cGMP regulations, Quva Pharma standards, and applicable regulatory requirements • Drives improvement of processes of the quality system • Performs assigned tasks and work to achieve company goals and department objectives • Tracks and/or manages Corrective and Preventative Action (CAPA) actions as they apply to Data Integrity Compliance • Assists in customer and/or regulatory audits • Verification of templates and SKU data • Check eBR and assign template in Infor for new SKUs • Verify Quva field data for entries created for eBR and maintain as necessary • Assist MC with template creation as necessary • Infor integration-provide information as necessary • Update SOP and MC role matrix for eBR responsibilities

🎯 Requirements

• Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology preferred) • 5+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role • Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP) • Knowledgeable in Quality Management Systems • Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints • Ability to audit GxP processes and Quality Management Systems • Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit report • 18+ years of age • Able to successfully complete a drug and background check • Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas.

🏖️ Benefits

• Set, full-time, consistent work schedule • Comprehensive health and wellness benefits including medical, dental and vision • 401k retirement program with company match • 22 paid days off plus 8 paid holidays per year • Occasional weekend and overtime opportunities with advance notice • National, industry-leading high growth company with future career advancement opportunities