AbbVie

Quality Laboratories Analyst - Microbiology

Employer
AbbVie
Location
Waco, TX, United States
Posted
Nov 13, 2020
Ref
203349
Required Education
Bachelors Degree
Position Type
Full time
Coordinates and supports laboratory testing, product disposition, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology as well as regulatory requirements. May be responsible for leading a functional sub-team.

This position is responsible for the following:
  • 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.
  • 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.


Qualifications

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.

Experience & Education
  • Bachelor's Degree in Microbiology or related Biological Sciences
  • Minimum 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.
  • Minimum of two (2) years directing a functional team.
  • Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.
  • Experience in th emanufacture of pharmaceuticals with knoledge of water systems, clean rooms, and aseptic filling and process validation.
  • Experience working in a GMP regulated environment preferred.
  • Audit experience preferred.


Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.