Quality Assurance Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $104.3k - $141.1k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide quality assurance support to the Product Quality organization as a subject matter expert in quality systems and records • Collaborate with Product Quality and functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process Development • Lead and deliver QA responsibilities while owning, reviewing and/or approving Product Quality records and documentation • Approve commercial variation records (GDCR) • Provide training to other staff as needed • Execute transactions in GMP systems including Veeva CDOCS and Trackwise • Support annual product reviews and site audits • Manage products in annual product review cycles • Provide QA support to clinical and commercial products in collaboration with Product Quality Leaders and Principal Product Quality Leaders • Own, review and approve protocols, reports, specifications, IPCs and annual product reviews • Execute transactions as owner and/or QA contact in Veeva CDOCS, change control and deviation/CAPA systems • Support audits, inspections, APR management and other processes • Support and facilitate continuous improvement initiatives for Quality Systems efficiencies • Interact with Corporate Quality, International Quality, Quality Control, Regulatory, Process Development, Site Quality Assurance, Supply Chain and Manufacturing

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience OR Bachelor’s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience OR Associate’s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience OR High school diploma/GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience • Understanding of pharmaceutical sciences, quality, compliance and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or commercial products • General understanding of biopharmaceutical bulk and drug product development and manufacturing • General knowledge of cGMPs • Previous experience using Veeva, Trackwise and other Amgen quality systems • Quality Assurance experience reviewing and approving cGMP documentation • Strong investigation skills related to Deviations/CAPAs/EVs and/or experience owning change control records • Experience with Amgen variation management processes and systems • Experience working on a cross-functional team in a matrix environment • Strong project management skills • Excellent written and verbal communication, facilitation and presentation skills • Competency in interacting with Senior Management • Strong organizational skills and ability to manage and prioritize multiple/competing tasks and deliverables

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support