Sunday , October 25 2020

Amgen Jobs – Specialist Quality Assurance: Environmental Monitoring

Website Amgen

Job Description:

As part of the Amgen’s Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.

The Quality Assurance Specialist is accountable for activities associated to Environmental and Critical Utilities Monitoring Program, including but not limited to; trend analysis, laboratory investigations and change control in a dynamic team environment.

Job Responsibilities:

  • Follow safety guidelines, cGMPs and other applicable regulatory requirements
  • Author technical documents (e.g. Environmental/Utilities Quarterly Reports)
  • Perform trend analysis of generated environmental and utility monitoring QC data Lead laboratory investigations and audits
  • Provide technical expertise in environmental and utility monitoring
  • Maintain training compliance and proficiency

Job Requirements:

  • Analytical skills to identify potential improvement opportunities
  • Ability to tactfully negotiate and positively influence peers and executive leadership
  • Established Leadership capabilities
  • Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
  • Passion for Operational Excellence
  • Financial acumen
  • Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
  • Communications skills, both oral and written, including executive presentation skills

Qualification & Experience:

  • Experience in technical writing skills within a highly regulated environment
  • Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
  • Background in audit settings
  • Experience in the following areas: QC Microbiology methods, Environmental Monitoring, Endotoxin testing, Growth Promotion testing, Water sampling, Bioburden testing and Result Reporting
  • Previous experience in a regulated GMP environment
  • Proven statistical knowledge, ability to trend data and apply corrective actions to interpretations of complex data sets
  • Previous investigational and problem-solving skills related to nonconforming events
  • Operation, maintenance, and troubleshooting experience with Environmental Monitoring equipment and instrumentation
  • Exposure to regulatory agency inspectors (or participation in regulatory agency audits)

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Functions: Quality Assurance

Job Location: Woburn, MA, US

Application Deadline: N/A

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