Quality Complaints Specialist

🔥 23 minutes ago

🇺🇸 United States – Remote

💵 $101k - $136.6k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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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

• Amgen is seeking a Specialist Quality Complaints Standard/Advanced Complaint Owner and member of the Product Complaints and Surveillance team • The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations • Determines corrective actions with their effectiveness • Determines the steps necessary to ensure the proper level of control for product in distribution • Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records • Ensures quality of complaint records • Facilitate cross-functional meetings to plan and coordinate the plan for closure of records • Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information • Completes prioritized work plans • Quickly advances issues that could impede the ability to close records according to action plans • Maintains compliance with local and global processes • Execution of regulatory and SOP requirements • Anticipates and prevents potential issues with regulators • Provides guidance and technical advice • Evaluates subject matter specialist assessments • Raises potential Quality issues to Management

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of quality experience OR Bachelor’s degree and 4 years of quality experience OR Associate’s degree and 8 years of quality experience OR High school diploma / GED and 10 years of quality experience • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry • Bachelor’s Degree in a Science Field • Ability to oversee multiple projects simultaneously • Ability to successfully manage workload to timelines • Familiarity with basic project management tools • Ability to negotiate a position after taking feedback from multiple sources • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) • Ability to travel +/- 10% of time to domestic and international Amgen sites

🏖️ 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 • flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.