GMP Quality Assurance Specialist

Job not on LinkedIn

November 21

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

💵 $87k - $107k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

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Madrigal Pharmaceuticals

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Pharmaceuticals • Biotechnology • Healthcare Insurance

Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The company achieved a significant milestone with the accelerated FDA approval of its first therapy for adults with NASH with moderate to advanced liver fibrosis. Madrigal is actively conducting a Phase 3 trial for the treatment of NASH with compensated cirrhosis. The company is dedicated to improving care for patients with NASH/MASH through its ambitious research programs and therapeutic developments.

51 - 200 employees

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $259M Post-IPO Equity on 2022-12

📋 Description

• Serve as a primary point of contact for the intake and logging of quality events (deviations, change controls, OOS) • Assist in the initial classification and risk assessment of new events • Partner with cross-functional teams to facilitate timely investigations and follow-ups in the QMS • Ensure all relevant documentation is archived in the QDMS in a timely manner • Track the lifecycle of CAPAs from initiation through closure • Enter and/or assist others to enter all QEM documentation in a timely fashion • Assist in compiling, analyzing, and reporting on quality metrics and trends

🎯 Requirements

• 3+ years relevant experience • BS in scientific discipline • 2+ years of experience in a pharmaceutical and/or biotech manufacturing environment • Experience working with external suppliers and quality event management • Strong interpersonal, negotiation, presentation, and communication skills • Knowledge of FDA regulations and ICH Guidelines in the pharmaceutical and/or biotech manufacturing environment • Ability to make rational, timely, and compliant risk-based decisions • Experience with Veeva Quality/Docs and Veeva QMS modules is highly desirable.

🏖️ Benefits

• Comprehensive benefits • Flexible paid time off • Medical, dental, vision, and life/disability insurance • 401(k) offerings (traditional, Roth, and employer match) • Supplemental life insurance • Legal services • Mental health benefits through Employee Assistance Program