Quality Engineer
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Nov 20, 2024 | |
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Position Title: Quality Engineer
Length of Assignment: 6 months Location/Site: US-IL-Lake County Interviewing Process: Onsite panel interview Responsibilities : 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. Support the ensure that all quality goals are met, and all practices and procedures comply with *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 FMEA's. *Develops and implements statistical quality programs and process monitoring systems. For specific U.S. manufacturing sites, performs batch release. Qualifications : 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. | |