Quality Engineer I

Position Summary

The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE will coach manufacturing personnel, on proper GMP and procedural compliance and empower them to identify and escalate quality issues, to ensure a quality product. The QEs are responsible for performing Safety Inspections on a scheduled frequency; they will identify and correct GMP issues while being expected to provide recommendations to management on corrective actions.

3rd shift - Wednesday - Friday every other Saturday (6:00pm - 6:00am)

Essential Duties & Responsibilities

• Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance.


• Conducts real time batch record reviews in assigned areas.


• Reviews equipment logbooks and evaluates adjustments for impact to product quality.


• Create, review, and revise procedures and assist with CAPA investigations as applicable.


• Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.


• Provide input and decision making for quality in the manufacturing areas with regard to manufacturing events and deviations.  Provide corrective actions as necessary.


• Monitors assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.


• Performs quality review and approval of change control documentation related to preventive maintenance and calibration as assigned.


• Conduct Safety Inspections and take prompt action to eliminate work hazards.


• Initiate product and commodity restrictions in accordance with local procedures.


• Perform other related duties as assigned or required.


• Also provide similar quality oversight functions for satellite locations as assigned or required.

Knowledge, Skills & Qualifications

• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.


• Strong oral/written communications skills and leadership skills required.


• Ability to work well with all levels of personnel throughout the facility.


• Capable of rapidly absorbing technical data and the ability to apply this knowledge to a pharmaceutical manufacturing environment.

Education and Experience 

• Bachelor’s degree in Engineering or related field (STEM) from an accredited college or university is required


• 0-2 years of experience required


• Previous pharma experience, preferred.


• Experience in a clean room environment desirable.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment 

• The MQ Quality Engineer role receives general direction daily from MQ supervisor and receives direction from MQ management as needed. The position requires both performance of duties in a manufacturing and office environment.
  
  
  
  • While working in the manufacturing environment:
    
    
    
    • Work is performed in a clean room environment. This requires the ability to adhere to the GMP requirements of the area.
    
    
    • There are high noise areas, areas where radiological hazards or lasers may be encountered and/or areas where biological hazards may be encountered.
    
    
    • Must be able to occasionally move and lift objects of up to 40 lbs. unassisted
    
    
  
  
  • While working in the office:
    
    
    
    • This job operates in a professional office environment and routinely uses standard office equipment.