Quality Engineer I

About the Role

The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations, ensuring operations are conducted under a state of GMP compliance. The QE will coach manufacturing personnel on proper GMP and procedural compliance, empowering them to identify and escalate quality issues to ensure a quality product. QEs are responsible for performing Safety Inspections on a scheduled frequency, identifying and correcting GMP issues, and providing recommendations to management on corrective actions.

Shift

• Wednesday - Friday / every other Saturday (6:00pm - 6:00am)

Key Responsibilities

• Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance.
• Conduct real-time batch record reviews in assigned areas.
• Review equipment logbooks and evaluate 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 manufacturing areas regarding manufacturing events and deviations. Provide corrective actions as necessary.
• Monitor assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.
• Perform 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.
• Provide similar quality oversight functions for satellite locations as assigned or required.
• Perform other related duties as assigned or required.

Requirements & Tech Stack

• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation, and initiative.
• Strong oral/written communications skills and leadership skills.
• Ability to work well with all levels of personnel throughout the facility.
• Capable of rapidly absorbing technical data and applying this knowledge to a pharmaceutical manufacturing environment.
• Experience in a clean room environment is desirable.

Qualifications

• Bachelor’s degree from an accredited college or university, preferably in Engineering or the sciences (Biology/Chemistry/Microbiology/Pharmacy).
• 0-2 years of experience required.
• Previous pharma experience is preferred.
• Must be at least 18 years of age.
• Typically requires travel less than 5% of the time.

Physical Requirements and Work Environment

• Receives general direction daily from MQ supervisor and direction from MQ management as needed.
• Requires performance of duties in both manufacturing and office environments.
• Manufacturing Environment:
• Work is performed in a clean room environment, requiring adherence to GMP requirements.
• May encounter high noise areas, radiological hazards, lasers, and biological hazards.
• Ability to occasionally move and lift objects of up to 40 lbs. unassisted.
• Office Environment:
• Operates in a professional office environment and uses standard office equipment.