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Manager Quality Control - Microbiology Labs

Amgen

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Location:
United States, Juncos

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Lead all microbiology laboratories during the night shift—ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety around the clock.

Job Responsibility:

  • Lead and develop a successful QC team, fostering a culture of safety, compliance, and continuous improvement
  • Oversee daily QC operations to ensure timely, accurate, and reliable testing aligned with production schedules
  • Serve as the QC subject matter expert during audits and inspections, ensuring inspection readiness
  • Provide technical guidance and troubleshooting support for complex assays and testing issues
  • Drive training initiatives and ensure team members are appropriately cross-trained for operational flexibility
  • Monitor assay results and documentation to ensure compliance with cGMP, SOPs, and regulatory standards
  • Communicate clear expectations on safety, quality, and compliance, addressing discrepancies promptly
  • Organize and prioritize team tasks based on impact and deadlines, adjusting as needed to meet changing requirements
  • Use data and dashboards to monitor QC performance metrics, identify trends, and implement improvements
  • Collaborate with cross-functional stakeholders to align QC activities with broader site and organizational goals
  • Empower team members through coaching, feedback, and development plans tailored to individual strengths
  • Promote continuous improvement initiatives to optimize workflows, increase efficiency, and reduce cycle times

Requirements:

  • Doctorate degree
  • OR Master’s degree and 3 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • OR Bachelor’s degree and 5 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • OR Associate’s degree and 10 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • OR High school diploma / GED and 12 years of Manufacturing Support, Quality Control and/or Laboratory experience
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to have:

  • Educational background in Life Sciences (Biology, Microbiology, Immunology, Genetics, or Molecular Sciences)
  • Experience in Quality and/or Laboratory operations within a GMP environment
  • Expertise in overseeing microbiology laboratory operations, including quality control testing for microbial contamination and microorganism identification studies
  • Knowledge of method transfer and validation activities
  • Familiarity with USP, EP, and JP pharmacopoeial standards and their application
  • Proven ability to drive continuous improvement in laboratory efficiency and productivity
  • Experience collaborating effectively with diverse cross-functional teams
  • Strong team development and leadership skills, with a focus on coaching and engagement
  • Excellent communication skills (written and verbal) in English and Spanish
  • ability to facilitate and present effectively
  • Demonstrated critical decision-making skills in a fast-paced environment
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
  • 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 and an annual site shutdown

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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