Quality Laboratory 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

Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system.

Responsibilities

• Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.
• Performs, coordinates and supports method validations and prepares final reports documenting the validation findings.
• Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing.
• Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.
• Reviews and approves all laboratory testing documentation.
  Responsible for the preparation of Test Failure Investigation reports.
• Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in SAP and LIMS.
• Responsible for leading others indirectly.
• Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.
• Must make sure that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOP’s are available to all laboratory personnel
• Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.

Qualifications

• Bachelor’s Degree in Microbiology or