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Senior Quality Engineer (GMP)
Senior Quality Engineer (GMP)BioSpace • Wyandotte, MI, US
Senior Quality Engineer (GMP)

Senior Quality Engineer (GMP)

BioSpace • Wyandotte, MI, US
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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

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, corrective and preventive actions 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 compliance for the manufacturing plant.

Supports the Quality Engineering group by auditing commissioning and validation documentation, authoring and executing qualification / validation protocols, reviewing and approving critical maintenance routines, and other quality assurance tasks.

Responsibilities

  • Implement and maintain the effectiveness of the Quality System.
  • Support the achievement of quality goals, ensuring practices and procedures comply with company policies and regulations.
  • Investigate plant events thoroughly, document accurately, and include findings in the CAPA system. Perform product impact analyses and place products on QA hold when necessary.
  • Maintain effective relationships with other Quality areas and Plant departments.
  • Participate on the Validation Review Board as the Manufacturing Quality Assurance representative.
  • Approve SOPs, ensuring compliance and clarity.
  • Approve calibration requests with appropriate product / process limits.
  • Audit commissioning and validation documentation.
  • Develop product quality plans, specifications, risk analyses, and FMEAs. Implement statistical quality programs and process monitoring systems.
  • Perform batch release for specific U.S. manufacturing sites.

Qualifications

  • Bachelor's degree in Biology, Chemistry, or Engineering.
  • 6+ years of experience in Manufacturing, Quality, or Engineering.
  • Strong verbal and written communication skills.
  • Good problem solving and analytical skills.
  • Interpersonal and communication skills.
  • Knowledge of quality and compliance management, regulations, and standards affecting API, Bulk Drug, or Finished Goods manufacturing.

    • Additional Information

    Range of pay is based on location and other factors. Benefits include paid time off, health insurance, 401(k), and participation in incentive programs. Pay details are at the company's discretion and subject to change.

    AbbVie is an equal opportunity employer and is committed to diversity and inclusion. For more info, visit here. Applicants seeking accommodations can find more info here

    Additional Details

  • Seniority level : Mid-Senior level
  • Employment type : Full-time
  • Job function : Quality Assurance
  • Industries : Pharmaceutical

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    Senior Quality Engineer • Wyandotte, MI, US