Monday , October 26 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
  • Maintain training compliance and proficiency
  • Perform trend analysis of generated environmental and utility monitoring QC data Lead laboratory investigations and audits
  • Provide technical expertise in environmental and utility monitoring
  • Author technical documents (e.g. Environmental/Utilities Quarterly Reports)

Job Requirements:

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

Qualification & Experience:

  • Bachelor’s degree and 5 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
  • High school diploma / GED and 12 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
  • Associate’s degree and 10 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Job Details:

Company: Amgen

Vacancy Type: Full Time

Job Functions: General Business

Job Location: Woburn, MA, US

Application Deadline: N/A

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