QA Operations Specialist - Allergan : Job Details

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 – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

We are looking for a Quality Assurance Operations Specialist to drive the deployment of quality systems that support the release of manufactured batches. This role ensures the internal release of raw materials, semi-finished, and finished goods, as well as the approval of equipment and utilities before use in manufacturing and testing activities.

Key Responsibilities

Product Release & Compliance

• Oversee the internal release of raw materials, intermediates, and finished products, ensuring all manufacturing and testing requirements are met.
• Manage the release schedule while ensuring strict adherence to quality standards.
• Support cross-functional teams in document revisions and approvals, maintaining data integrity within the role's scope.

Qualification & Validation

• Act as the Quality Subject Matter Expert (SME) for projects related to infrastructure, utilities, and equipment (IUE qualification & validation).
• Review and approve qualification documents.
• Develop and assess validation plans & summary reports.
• Participate in risk management reviews related to quality and regulatory compliance.
• Approve calibration documents, ensuring systems align with QPP06 standards for computerized validation (CSV).
• Lead training programs related to quality processes and compliance.
• Serve as the site representative at the corporate level for IUE qualification and validation activities.
• Act as the QA representative for pest control management.

Stability & Compliance

• Oversee the stability management process, ensuring the implementation of stability requirements.
• Approve stability protocols & reports in alignment with regulatory standards.
• Participate in risk management reviews related to stability compliance.

Investigations & Continuous Improvement

• Conduct and review investigations related to non-conformities (LIR, NCRs).
• Act as the quality contact for approving low-risk investigations related to NCRs.
• Support internal and external audits, ensuring compliance with industry regulations.
• Drive continuous improvement initiatives across the QA Ops team and the broader site.
• Perform shop floor (GEMBA) audits to assess quality adherence.
• Provide coaching and Maximo system spot-checks to enhance operational efficiency.

• Scientific Master's degree or equivalent.
• Proven experience in QA/QC, engineering, or manufacturing, ideally in the pharmaceutical industry.
• Strong GxP knowledge to ensure compliance with industry standards.
• Fluent in French andEnglish (B2), with proficiency in both speaking and writing.

AbbVie Culture

At AbbVie, we care deeply about bringing innovative solutions to patients in need. By joining us, you'll be at the forefront of our mission, working in a dynamic and supportive environment that encourages growth and collaboration.

• All4OneAbbVie: Foster strong interpersonal relationships and teamwork.
• Decide Smart & Sure: Navigate ambiguity and make informed decisions.
• Agile & Accountable: Communicate a clear and inspiring vision.
• Clear & Courageous: Provide honest and constructive feedback.
• Make Possibilities Real: Efficiently plan and execute tasks while adapting to challenges.

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.

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