Quality Engineer I

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.

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

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.

Education and Experience

• 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 required

• Previous pharma experience, preferred.

• Experience in a clean room environment desirable.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

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.