Quality Assurance Specialist - 2nd shift (3pm - 11:30pm)

About the role

This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation.

Work schedule is 2nd shift (3pm - 11:30pm).

Responsibilities

• Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
• Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
• Review documentation associated with receipt, storage, and distribution
• Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
• Perform routine Quality Assurance assessments and provide direct operational oversight
• Offer leadership, guidance, mentorship, and training to staff and partner organizations
• Manage oversight of logistic and transportation service providers
• Provide expert advice on quality matters to operational teams and cross-functional groups
• Ensure staff complete necessary training related to Amgen business operations
• Achieve established metric targets and develop standardized approaches for tracking progress
• Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
• Participate in quarterly business and quality reviews and address any service failures with LSPs
• Present updates on LSP Quality Management System health and initiatives at management reviews
• Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
• Support internal and external audits and inspections as a member of the audit/inspection team
• Implement business continuity plans for services and processes
• Form strategic partnerships with internal customers and external vendors to ensure operational success
• Integrate risk management strategies into overall supply chain management
• Lead initiatives, programs, and projects targeting operational improvements
• Develop solutions that are comprehensive, practical, and align with functional goals
• Perform additional duties as assigned by management

Requirements

Basic Qualifications

• Doctorate degree
• OR Masters degree and 2 years of quality assurance experience
• OR Bachelors degree and 4 years of quality assurance experience
• OR Associates degree and 8 years of quality assurance experience
• OR High school diploma / GED and 10 years of quality assurance experience

Skills

Preferred Qualifications

• Skills in Continuous Improvement/Process Optimization
• Technical aptitude: Digitally and AI savvy
• Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
• Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
• Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
• Expertise in managing deviations, change controls, and CAPAs
• Proficiency in Veeva, SM LIMS, and ERP systems
• Knowledge of industry standards (GMP, GDP, Import/Export)
• Commitment to exemplifying Amgen’s core values
• Demonstrated self-leadership and motivation
• Strong critical thinking skills
• Ability to evaluate compliance issues and engage with regulatory inspectors
• Experience managing multiple priorities within a dynamic environment
• Direct experience with drug substances and/or drug products
• Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
• Track record of representing an organization during regulatory interactions
• High proficiency in Microsoft Excel, Word, and PowerPoint

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, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.