Engineer I-Manufacturing Quality
Engineer I-Manufacturing Quality
Posted on :
23-10-2024
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Job Description
Title: Quality Engineer
Location: Austin TX
Type: Contract
Shift Timings: 6:00 PM 6:00 AM
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
- Bachelors degree in Engineering or related field (STEM) from an accredited college or university is required
- 02 years of experience required
- Previous pharma experience preferred.
- Experience in a clean room environment desirable.
Travel Requirements
- Typically requires travel less than 5% of the time
Physical Requirements and Work 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
Additional Details
- Does the position allow for the worker to be virtual/remote : No
- Shore Options Available for this Position : Onshore Only
- Critical Position : No
- Professional References Required for this position : No
- Driving Assignment : No
- Timekeeping Method : Direct Entry
- Job Posting Description Comments : TBD
- Select Shift &Schedule : Austin TXProfessionalThird ShiftSee Below
- Enter Shift Times : 6PM 6AM
Employment Type
Full Time
Key Skills
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