Quality Control Analyst

Purpose

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 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.
• Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.
• Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.
• Experience working in a GMP regulated environment preferred. Audit experience preferred.