Engineer I, 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 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