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Quality Assurance III, Advance Surgery

Req #: 180006L7_en
Location: Hayward, CA US
Job Category: Quality
Date Posted: 4/3/2018 3:48:47 PM
Baxter International

Description

Managing the QC Lab Operations, lead investigating the micro excursions through all stages of the manufacturing process from incoming raw materials to finished goods.
 

·         Managing the QC Lab operations and micro testing processes (supplier micro testing)
·         Lead micro investigations
·         Manage the use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
·         Ensure completion of all testing, including special project / protocol testing in a timely and appropriate manner.
·         Initiate and investigate deviations and change control activities (Impact assessment/task owner/change owner).
·         Ensure LIR investigation timeliness and robustness
·         Write and execute equipment and test method qualification protocols and reports
·         Initiate and obtain applicable approval for test requests
·         Initiate and follow continuous improvement practices (QLP, 6S, LEAN, Kaizen etc.)
·         May work on special projects / protocol testing that involves new methods and instrumentation
·         Serve as mentor to QC team.  Provide training and work direction to plant during lab testing investigations
·         Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
·         Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
·         Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
·         Perform equipment maintenance and calibrations as required.
·         Perform equipment qualification activities.
·         Perform test method validation or assessment activities.
·         May perform other duties as assigned.
·         Identify and troubleshoot equipment problems
·         Interact with Vendors for technical support
·         Present metric to management and cross-functional team (when needed)
 
·         Support internal and external audits.
·         Initiate department purchase orders
 
 

 

Qualifications

 
Qualifications
·         Proficient in advanced wet and instrumental methods of analyses.
·         Advanced laboratory skills and knowledge of statistical method.
·         Strong technical problem solving skills
·         Ability to handle multiple tasks concurrently, and in a timely fashion.
·         Must communicate effectively (verbal and written) with supervisors and peers.
·         Must demonstrate effectiveness in ability to train others
·         Knowledge of most laboratory equipment including but not limited to autoclaves, incubators, analytical equipment
·         Must be proficient in a variety of mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
·         Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
·         Knowledge of advance chemical/micro procedures.
·         Knowledge of data integrity
·         Good computer skills, knowledge of Microsoft Word, Excel and PowerPoint.
 
 
Education and/or Experience
Bachelors Degree in Biology , Microbiology  with Analytical Chemistry or Laboratory coursework, with 7+ years experience, or Masters Degree in Biology/Microbiology, with 1-4 years experience. At least 5 years manager experience
 
Physical Demands
·         Regular attendance is necessary to perform the essential functions of the job.
·         Light work, frequent lifting up to 10 lbs; frequent standing/walking.
 
 
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
 
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