Engineer, Quality

Role Summary

The Quality Engineer is responsible for manufacturing quality assurance functions within the plant, including deviation resolution, product impact analysis, and corrective and preventive action for events; leading and participating in investigations; approving standard operating procedures; overseeing the plant calibration program; quality improvement programs; and ensuring cGMP and Abb Vie policy compliance for the manufacturing plant.

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under the individual's responsibility.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant systems. 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.
• Write and/or approve 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.
• Support the batch release process.
• Conducts regular process reviews and retrospectives to drive continuous improvement.
• Resolve quality issues for assigned value streams.
• This position requires the candidate to work onsite five days a week Tuesday-Saturday.
• Hours:
  
  9:00AM-6:00PM.

• Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience
• 2+ 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