Detail of : Quality Laboratories Analyst - Microbiology Job Opening in Waco
About ’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about , please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description 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.
Equal Employment Opportunity
At , 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
If you strong confindence you meet the requirement above, please register and sign in to AbbVie e-recruitment website with link as follow :
Application will be treated strictly confidential .
Only qualified, short-listed applicants will be invited for furthers process.
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