drjobs Senior Engineer, Quality

Senior Engineer, Quality

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1 Vacancy
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Job Location drjobs

North Chicago, IL - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Purpose
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations performance of product impact analysis and corrective and preventive action for events leading and participating in investigations approval of standard operating procedures oversight of the plant calibration program quality improvement programs and assurance of cGMP and Abbott policy compliance for the manufacturing plant.

Support the Quality Engineering group by auditing of commissioning and validation documentation completed by others authoring and execution of newly identified qualification/validation protocols review and approval of critical planned maintenance routines and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

Responsibilities

  • 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.
  • Ensure 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.
  • Maintain an effective liaison and cooperative relationship with other Quality areas and Plant departments.
  • Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
  • Approve standard operating procedures; ensure procedures comply with policy and make sense.
  • Approve calibration requests and ensure that these requests have appropriate product/process limits assigned.
  • Audit commissioning and validation documentation.
  • Develop product quality plans documents and systems by creating product specifications quality specifications quality plans risk analyses and FMEAs. Develop and implement statistical quality programs and process monitoring systems.
  • For specific U.S. manufacturing sites perform batch release.

Qualifications :

  • Bachelors degree preferably in Biology Chemistry or Engineering.
  • 6 years of overall experience in Manufacturing Quality or Engineering.
  • Good verbal and written communication skills.
  • Good problem solving and analytical skills.
  • Good negotiation skills.
  • Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.


Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

  • We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

  • This job is eligible to participate in our shortterm incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No


Employment Type :

Fulltime

Employment Type

Full-time

About Company

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