Quality Engineer I

Otsuka ICU Medical•Austin, TX

About The Position

The Manufacturing Quality, Quality Engineer I (QE) provides oversight and guidance in manufacturing operations to help ensure they operate in a state of GMP compliance. The QE coaches manufacturing personnel on proper GMP and procedural compliance and empowers them to identify and escalate quality issues to ensure product quality. The role also performs scheduled safety inspections, identifies and corrects GMP issues, and provides management with recommendations for corrective actions. The position receives general daily direction from the MQ supervisor and direction from MQ management as needed. Duties are performed in both manufacturing and office environments, including clean room work requiring adherence to applicable GMP requirements. The role may also provide quality oversight at assigned satellite locations and typically requires less than 5% travel.

Requirements

Bachelor’s degree from an accredited college or university.
0–2 years of experience.
Must be at least 18 years of age.
Exceptional interpersonal skills and a proven track record of teamwork, adaptability, innovation, and initiative.
Strong oral and written communication skills and leadership skills.
Ability to work well with all levels of personnel throughout the facility.
Ability to rapidly absorb technical data and apply that knowledge in a pharmaceutical manufacturing environment.
Ability to adhere to GMP requirements in a clean room environment.
Ability to occasionally move and lift objects weighing up to 40 pounds unassisted.

Nice To Haves

Bachelor’s degree preferably in Engineering or a science such as Biology, Chemistry, Microbiology, or Pharmacy.
Previous pharmaceutical experience.
Experience in a clean room environment.

Responsibilities

Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to verify procedures are followed in accordance with GMP requirements.
Conduct real-time batch record reviews in assigned areas.
Review equipment logbooks and evaluate adjustments for their impact on product quality.
Create, review, and revise procedures and assist with CAPA investigations as applicable.
Analyze data, identify corrective and preventive actions, and implement process improvements focused on quality processes.
Provide quality input and make decisions in manufacturing areas regarding manufacturing events and deviations, and provide corrective actions as necessary.
Monitor assigned areas for compliance with procedures and cGMPs related to equipment, documentation, and personnel.
Perform quality review and approval of assigned change control documentation related to preventive maintenance and calibration.
Conduct safety inspections and take prompt action to eliminate work hazards.
Initiate product and commodity restrictions in accordance with local procedures.
Provide similar quality oversight functions for satellite locations as assigned or required.
Perform other related duties as assigned or required.