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Quality Engineer

2 months ago

North Chicago, United States Synectics Full time

Description

  • Supports the plant Exception Report/CAPA System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for product manufacturing and packaging.
  • Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements.
  • Coordinates the exception document process and creates exception documents
  • Independently leads complex, high impact investigations
  • Ensures all investigations are written according to corporate and site requirements
  • Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
  • Ensures all Quality CAPA goals and metrics are met
  • Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions.
  • Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant.
  • Responsible for summarizing non conformances and create reports using templates.
  • Lead successful meetings and work with different teams.
Qualifications
  • Bachelor degree, preferably in one of the following areas: Biology, Chemistry or Engineering
  • 4-6 years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering (experience over education preferred)
  • Demonstrates ability to problem solve and utilize analytical skills
  • Knowledge of Quality/Compliance management, Regulations and Standards
  • Must have good technical writing skills.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.