Microbiology Quality Laboratory Analyst

Job Summary 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.
May be responsible for leading a functional sub-team.
Job Details · 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 implements a corrective action.
· Assists in reviewing and approving laboratory testing documentation.
· Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in SAP and LIMS.
· Responsible for the preparation of Test Failure Investigation reports.
· 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.
· Perform any other tasks/duties as assigned by manager.
Education and Experience: Minimum requirements for this position are: Education - Bachelor’s Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience.
Experience: Technical - 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.
Experience: BT Systems - Advanced Microsoft Office and SAP user experience preferred.
Knowledge of LIMS and Trackwise preferred Experience: Regulatory - Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.
Experience: Aseptic - Experience working in a GMP regulated environment preferred.
Audit experience preferred.
Essential Knowledge, Skills & Abilities: · Knowledge of scientific theories, principles and techniques used in microbiological or analytical test procedures.
· Knowledge of cGMP’s and regulations and experience.
· Knowledge of aseptic and experimental techniques with excellent attention to detail.
· Strong interpersonal and presentation skills with the ability to communicate clearly and professional, written and verbally.
· Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
· User knowledge of Microsoft Office and computerized inventory systems (SAP preferred), with an ability to learn other computer-based systems.
User knowledge of LIMS and TrackWise.
· Ability to read, comprehend, write, and communicate effectively in English.
· Ability to manage multiple tasks with competing priorities.
· Ability to understand and author technical reports.
· Experience using and maintaining analytical equipment.
· Excellent analytical and problem-solving skills.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.