Engineer I, Quality
About The Position
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.
Requirements
- 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)
- 0-2 years of experience
Nice To Haves
- Previous regulated industry experience, preferred.
- Experience in a clean room environment desirable.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
