Job Description

Job Description

Job Description

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.

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