Role Information

As a Manufacturing Quality Assurance Engineer at Agilent, you will be at the forefront of ensuring that our life-saving products meet the highest standards of safety and efficacy. This role is a critical link between our manufacturing operations and our commitment to global health. Based in our state-of-the-art Frederick, CO facility, you will provide essential quality oversight, technical expertise, and leadership to ensure our processes remain compliant and efficient.

The Manufacturing Quality Assurance Engineer provides comprehensive support for reviewing batch records and approving critical information generated to support batch disposition. This position directly supports manufacturing processes and related assignments, requiring a professional who thrives in a real-time, fast-paced production environment.

Key Responsibilities

In your capacity as a Manufacturing Quality Assurance Engineer, your daily activities will focus on maintaining the integrity of our CGMP operations:

1. Quality Engineering and Guidance

Provide expert guidance to ensure that process, data, and product quality consistently meet internal requirements and external regulatory standards.
Act as a Subject Matter Expert (SME) during manufacturing operations, offering real-time quality review and decision-making support.
Review product and process quality data to identify trends, ensure adherence to specifications, and mitigate risks before they impact the supply chain.

2. Batch Record Review and Disposition

Perform meticulous reviews of batch production records to ensure all documentation is accurate, complete, and compliant with Standard Operating Procedures (SOPs).
Approve information generated during the manufacturing process that is essential for final batch disposition.
Coordinate with the Quality Control (QC) and Production teams to resolve discrepancies found during the record review process.

3. Process Improvement and Problem Solving

Solve problems of moderate complexity related to manufacturing deviations, non-conformances, and CAPA (Corrective and Preventive Actions).
Lead or support continuous improvement initiatives (Lean/Six Sigma) within the Quality department to streamline documentation and increase operational throughput.
Utilize digital solutions and SAP to optimize and maintain state-of-the-art manufacturing processes.

4. Cross-Functional Collaboration

Partner with Material Management, Planning, Procurement, and Technical Services to ensure that new product introductions (NPI) transition seamlessly from prototype to full production.
Participate actively in the creation and approval of equipment and process SOPs.
Train and mentor manufacturing personnel on quality principles and CGMP requirements.

Qualifications and Requirements

To be successful as a Manufacturing Quality Assurance Engineer, candidates should possess the following qualifications:

Education: Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Chemical), Biology, Chemistry, or a related scientific field.
Experience: Typically 4+ years of relevant experience in a Quality Assurance or Quality Engineering role within a regulated industry (Pharmaceuticals, Biotech, or Medical Devices).
CGMP Knowledge: In-depth knowledge of Current Good Manufacturing Practices (CGMP) requirements related to manufacturing operations is mandatory.
Technical Skills: * Proficiency in technical writing for SOPs, deviations, and reports.
1. Strong analytical and problem-solving skills.
2. Familiarity with SAP or similar Enterprise Resource Planning (ERP) systems is highly preferred.
3. Experience with root cause analysis (RCA) and risk management tools (FMEA).
Soft Skills: Ability to work independently with minimal supervision while maintaining high levels of collaboration across departments. Excellent communication skills are essential for interfacing with diverse technical teams

To apply for this job please visit agilent.wd5.myworkdayjobs.com.

Manufacturing Quality Assurance Engineer