Engineer , Quality

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 elevate 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.

• 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.

• 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.

• Must be at least 18 years of age.
• Bachelor's degree from an accredited college or university is required, preferably in Engineering or the sciences (Biology/Chemistry/Microbiology/Pharmacy).
• Previous regulated industry experience, preferred.
• Experience in a clean room environment desirable.

• 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.
• Typically requires travel less than 5% of the time