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Manager Quality Control - Biochemistry Labs

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Amgen

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Location:
United States , Juncos

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Lead all Biochemistry laboratories during the night shift (including Wet Chemistry and HPLC Labs) —ensuring compliant, accurate testing and fostering an impactful team that safeguards product quality and patient safety.

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, Chemistry, Biochemistry, or related fields
  • Experience in Quality and/or Laboratory operations within a GMP environment
  • Expertise in overseeing biochemistry laboratory operations, including Wet Chemistry and HPLC testing
  • Strong knowledge of analytical techniques such as HPLC, TOC, UV spectroscopy, pH, conductivity, appearance, color, clarity, polysorbate, physical methods
  • Familiarity with laboratory systems such as LIMS, LMES, CIMS, and Empower for HPLC data management
  • Knowledge of method transfer and validation activities
  • Proven ability to optimize schedules and improve laboratory efficiency and productivity
  • Strong people management skills, including team development, coaching, and engagement
  • Demonstrated ability to balance working both independently and in teams, driving cross-shift collaboration and efficiency with other managers within the organization
  • Highly collaborative leadership style with experience working effectively across diverse departmental groups
  • Excellent communication skills (written and verbal) in English and Spanish
  • ability to facilitate and present effectively
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
Job Link Share:

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