Manufacturing Quality Assurance Engineer - (Night Shift)

Agilent TechnologiesBoulder, CO
$82,480 - $128,875Onsite

About The Position

Agilent Technologies is seeking a Quality Assurance Engineer to join their Manufacturing team. This role is crucial for ensuring that high-quality products are designed, engineered, and manufactured in conformance with required standards and regulations. The QA Engineer will provide real-time, on-the-floor quality support during manufacturing operations in a GMP-regulated environment, review batch records, collaborate with cross-functional teams to address quality issues, and contribute to continuous improvement initiatives. The position is based in Colorado and supports the development and commercialization of nucleic acid therapeutics.

Requirements

  • Bachelor's or Master's degree in a relevant scientific or engineering field.
  • 2+ years of experience in a quality assurance or regulated manufacturing environment.
  • Proven understanding of GMP standards and quality system regulations (e.g., FDA, ISO).
  • Self-motivated, detail-oriented, and collaborative with strong communication skills.

Nice To Haves

  • Experience with batch record review and supporting real-time floor operations.
  • Oligonucleotide manufacturing experience is a plus.
  • Post-graduate certification or license may be required.

Responsibilities

  • Provide real-time, on-the-floor quality support during manufacturing operations to ensure product compliance with internal standards and external regulations (e.g., FDA, ISO).
  • Review executed batch records and in-process documentation to support timely API release.
  • Collaborate multi-functionally with Manufacturing, Materials, Quality Control, Engineering, and Facilities teams to address quality issues and drive resolution.
  • Contribute to problem-solving efforts and process improvements within defined objectives and growing responsibility.
  • Support internal audits, documentation practices, and adherence to GMP and quality system requirements.
  • Actively participate in team projects, share expertise, and help mentor less expert team members.
  • Participate in an on-call rotational schedule as part of the engineering quality team.

Benefits

  • Eligibility for bonus
  • Stock options
  • Benefits package
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