Engineer I, Quality

Description

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.

This role is 100% onsite at our Dublin OH manufacturing facility.

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.

Minimum Qualifications Education and Experience

• Must be at least 18 years of age
• Bachelors degree from an accredited college or university is required preferably in Engineering or the sciences (Biology/Chemistry/Microbiology/Pharmacy)
• 0-2 years of experience
• Previous regulated industry experience preferred.
• Experience in a clean room environment desirable.

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

Required Experience:

IC