Quality Lab Analyst

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 – and 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 Tik Tok.

Job Description

The Quality Lab Analyst is responsible for planning, coordinating, and/or implementing initiatives that provide quality assurance support for QC Lab Operations. Specific areas of support may include: GMP/Compliance; Change Management, Lab Equipment/Instrument procurement, installation, calibration, validation/qualification, Training and QC Lab support activities (like Testing, Stability Program and Data review). This position will help to ensure that the QC Labs operate in compliance with corporate and governmental regulations.

Responsibilities:

· Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed.

· Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed.

· Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures.

· Perform review and assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement improvements within the quality system.

· Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests.

· Participate on validation review board as area validation for equipment qualifications.

· Assist in the design of effective quality systems, procedures, and/or processes within cross functional te