Manufacturing Quality Engineer

Company: US Tech Solutions
Location: Austin
Posted on: August 6, 2022

Job Description:

Job Title: Manufacturing Quality Engineer ILocation: Austin, TX 78728Duration: 8/23/2022 to 8/22/2023
Job Description:
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.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.

Keywords: US Tech Solutions, Austin , Manufacturing Quality Engineer, Engineering , Austin, Texas