Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Job Title: Quality Engineer
Location: North Chicago IL 60064 Need Locals.
Any visa
Duration: 6 Months extension possible based on needs and performance
Maximum Salary: $30.00 per Hourly.
Job Description:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Company policies and applicable regulations for the Quality areas under his/her responsibility.
- Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system.
- Performs product impact analyses for plant events and places product on QA hold where appropriate.
- Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
- Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approves standard operating procedures; ensures procedures comply with policy and make sense.
- Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
- Auditing of commissioning and validation documentation.
- Develops product quality plans documents and systems by creating product specifications quality specifications quality plans risk analyses and FMEAs.
- Develops and implements statistical quality programs and process monitoring systems.
- For specific U.S. manufacturing sites performs batch release.
List required and preferred qualifications up to 10). Include education skills and experience.
- Bachelor degree preferably in Biology Chemistry or Engineering
- 3 years of overall experience in Manufacturing Quality or Engineering
- Good verbal and written communication skills.
- Good problem solving and analytical skills
- Good interpersonal relations / communications skills
- Good negotiation skills
- Knowledge of quality / compliance management as well as regulations and standards affecting
- API Bulk Drug or Finished goods manufacturing.
- Quality System
- Problem Solving
- Communication Skills
- Compliance Management
- Statistical Programs
- Risk Analyses
- FMEA
Employment Type
Full Time
