Quality Engineer

United Pharma; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma seeks a Quality Engineer to support quality and compliance in a GMP pharma/biotech manufacturing environment.

The role focuses on investigations, deviations, CAPA, change control, audits, quality systems, and continuous improvement, collaborating with Manufacturing, Engineering, Validation, QC, QA, and Facilities to ensure regulatory compliance.

You will review documentation, support regulatory inspections, and drive data-driven improvements to prevent recurrence.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of Quality Engineering/Quality Assurance experience in Pharma/Biotech/Medical Device/Life Sciences.
• Strong knowledge of GMP/GxP and FDA requirements.
• Experience with deviations, CAPA, change control, investigations, and risk assessments.
• Experience with quality systems and technical documentation.
• Knowledge of validation, qualification, and manufacturing processes.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, documentation, and communication skills.

Responsibilities

• Support GMP quality systems and manufacturing operations.
• Lead deviations, investigations, CAPA, and root cause analyses.
• Manage change controls, SOPs, specifications, and quality records.
• Support equipment, facility, utility, and process validation activities.
• Perform risk assessments and support quality improvement initiatives.
• Review manufacturing and validation documentation for GMP compliance.
• Support internal, customer, and regulatory audits.
• Monitor quality metrics and trends.
• Collaborate with Manufacturing, Engineering, Validation, QC, QA, and Facilities teams.
• Ensure compliance with FDA, GMP, GxP, 21 CFR and company procedures.
• Support continuous improvement and corrective/preventive actions.

Skills

GMP/GxP knowledge

FDA requirements

Deviations & CAPA

Change control

Investigations & risk assessments

Quality systems & documentation

Validation & manufacturing processes

Audits & regulatory inspections

Analytical & problem solving

Communication

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

We are looking for a Quality Engineer to support quality and compliance activities within a GMP Pharma/Biotech manufacturing environment. The role will focus on investigations, deviations, CAPA, change control, audits, quality systems, and continuous improvement.

Key Responsibilities:

• Support GMP quality systems and manufacturing operations.
• Lead and support deviations, investigations, CAPA, and root cause analysis.
• Manage and review change controls, SOPs, specifications, and quality records.
• Support equipment, facility, utility, and process validation activities.
• Perform risk assessments and support quality improvement initiatives.
• Review manufacturing and validation documentation for GMP compliance.
• Support internal, customer, and regulatory audits.
• Monitor quality metrics, trends, and recurring issues.
• Partner with Manufacturing, Engineering, Validation, QC, QA, and Facilities teams.
• Ensure compliance with FDA, GMP, GxP, 21 CFR, and company procedures.
• Support continuous improvement and corrective/preventive actions.

Skills & Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of Quality Engineering/Quality Assurance experience in Pharma, Biotech, Medical Device, or Life Sciences.
• Strong knowledge of GMP/GxP and FDA requirements.
• Experience with deviations, CAPA, change control, investigations, and risk assessments.
• Experience with quality systems and technical documentation.
• Knowledge of validation, qualification, and manufacturing processes.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, documentation, and communication skills.