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MQA Engineer (Onsite IL; Hybrid)

Employer
AbbVie
Location
Lake County, Illinois
Start date
Nov 17, 2023

Job Details

This position sits onsite 3 days weekly (2 days remote) at our North Chicago, IL headquarters.

Purpose:

The 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.

Responsibilities:

  • Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
  • Responsible for implementing and maintaining the effectiveness of the Quality System.
  • Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
  • 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.
  • Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

  • Qualifications:

  • 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.
  • AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.


    Company

    AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

    Stock Symbol: ABBV

    Stock Exchange: NYSE

    Company info
    Website
    Phone
    1-800-255-5162
    Location
    1 North Waukegan Road
    North Chicago
    Illinois
    60064
    US

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