AbbVie Quality Control Analyst responsible for microbiology lab investigations, method validations, and documentation in a GMP regulated environment. Supports laboratory testing, product disposition, and regulatory compliance.
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.
Bachelor’s Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience.
Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Knowledge of microbiology and regulatory requirements preferred.
Qualification
Knowledge of LIMS and TrackWiseAudit experience
Required
Bachelor’s Degree in Microbiology or related Biological Sciences
Minimum of three (3) years of lab experience
Two (2) years of experience in Industrial Microbiology with emphasis in Pharmaceutical and/or Medical Device industry or equivalent
Knowledge of microbiology and regulatory requirements
Experience in manufacture of pharmaceuticals with knowledge of water systems, clean rooms, aseptic filling, and process validation
