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 • Bachelor’s 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