Manufacturing Quality Engineer I

Job Summary

The Manufacturing Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations to ensure compliance with Good Manufacturing Practices (GMP).

The QE will coach manufacturing personnel on GMP compliance, address quality issues, and offer corrective actions.

Additionally, the QE will conduct safety inspections and provide recommendations for improvements to management.

Key Responsibilities

• Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure adherence to GMP procedures.
• Perform real-time batch record reviews in assigned areas.
• Review equipment logbooks and assess adjustments for their impact on product quality.
• Create, review, and revise procedures, and assist with Corrective and Preventive Actions (CAPA) investigations.
• Analyze data, identify corrective/preventive actions, and implement process improvements with a focus on quality.
• Provide input on quality issues in manufacturing, including making decisions related to manufacturing events and deviations.
• Monitor compliance in assigned areas for equipment, documentation, and personnel adherence to cGMP.
• Perform quality review and approval of change control documentation related to preventive maintenance and calibration.
• Conduct safety inspections and eliminate work hazards as identified.
• Initiate product and commodity restrictions following local procedures.
• Provide quality oversight functions for satellite locations as assigned.
  
  

Required Qualifications

• Bachelor’s degree in Engineering or a related field (STEM) from an accredited institution.
• 0-2 years of relevant experience.
• Previous experience in the pharmaceutical industry preferred.
• Experience working in a clean room environment is desirable.
  
  

Preferred Qualifications

• Strong oral/written communication skills and leadership ability.
• Exceptional interpersonal skills, adaptability, innovation, and initiative.
• Capable of understanding technical data and applying it to a pharmaceutical manufacturing environment.
  
  

Physical Requirements And Work Environment

• Work is performed in a clean room setting, with high noise levels, and potential exposure to radiological, laser, or biological hazards.
• Must be able to lift up to 40 lbs. unassisted.
• Office environment: Standard professional office setting using common office equipment.
  
  

Travel Requirements

• Typically requires less than 5% travel.
  
  

Skills: coaching,manufacturing,safety inspections,gmp,technical data analysis,pharmaceutical industry,stem field,interpersonal skills,adherence,quality issues,good manufacturing practices (gmp),compliance,office,physical requirements,oral/written communication,travel,clean room environment,change control documentation,process improvements