Manufacturing Quality Assurance Engineer - (Night Shift)

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.
• Role requires this team member participates in an on call rotational schedule as part of the engineering quality team.

Requirements

• Job Posting Qualifications
• Bachelor's or Master's degree in a relevant scientific or engineering field.
• 2+ year of experience in a quality assurance or regulated manufacturing environment.
• Proven understanding of GMP standards and quality system regulations (e.g., FDA, ISO).
• Experience with batch record review and supporting real-time floor operations preferred.
• Self-motivated, detail-oriented, and collaborative with strong communication skills.
• Oligonucleotide manufacturing experience is a plus.
• Post-graduate certification or license may be required.
• Additional Details
• This job has a full time weekly schedule. Applications for this job will be accepted until at least June 30, 2026 or until the job is no longer posted.

Benefits

Additional Information

Job Description The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in the capacity and expansion of its Colorado operations. Join our team of experts dedicated to the development and commercialization of nucleic acid therapeutics for life-changing, life-saving medicines. Agilent's Manufacturing team is seeking a Quality Assurance Engineer to join their team! The QA Engineer ensures that high quality products are designed, engineered and manufactured by Agilent, in conformance with required standards and regulations. In this position, quality, product regulation, and compliance positions may be in either the field or factory. In the field, they will act as a liaison between customers, distributors, authorities and Agilent's Factory Quality/Product Regulation & Compliance team. Day-to-day responsibilities include working on quality department assignments with clearly defined objectives such as: Join Agilent's mission to advance scientific discovery and improve lives. As a Manufacturing Quality Assurance Engineer, you'll play a meaningful role in maintaining the highest standards of quality and compliance in our oligonucleotide production facility. This is a phenomenal opportunity to support real-time manufacturing operations, give to continuous improvement initiatives, and ensure product and process integrity in a GMP-regulated environment. Shift: Onsite | Mon-Thurs, 8:00 PM - 6:30 AM (10-hour shift; flexible with discussion)

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Agilent? Share your experience