Quality Engineer in North Chicago, IL

Length of Contract: 6 months

Location/Site: US-IL-Lake County

Onsite role

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.

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