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Quality Supervisor

Req #: 180006LR_en
Location: Irvine, CA US
Job Category: Quality
Date Posted: 3/28/2018 2:21:08 PM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Description
Supervises a staff of QA analysts, inspectors and technicians to ensure that raw materials are in compliance with chemical, biological, microbiological and/or physical quality control programs and external regulations.

Essential Duties and Responsibilities
  • Plans and schedules the work of QA analysts, QA technicians and inspectors.
  • Ensures that all inspection and test procedures are properly completed and documented.
  • Reviews all quality assessment results and determines whether to accept or reject incoming raw materials during the inspection process.
  • Work closely with Production, Warehouse, R&D and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications and test methods. Where appropriate, simplifies and streamlines the process. 
  • Prepares routine reports and summary on incoming material inspections and supplier quality integrity.
  • Develops and maintains inspection documentation procedures, QA inspection instructions and department policy procedures. Ensures raw material compliance regulations are followed.
  • Hires, trains and evaluates all personnel. Makes wage and salary recommendations and maintains performance records.
  • Directly supervises in the Receiving and Inspection department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications

Qualifications for this role

  • Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.  Working knowledge of statistics and production processes.
  • Knowledge of GMP, GDP, and FDA required. Demonstrated attention to details and accuracy, required. Must have good communication skills. General Knowledge of quality inspection techniques, quarantine procedures, and warehouse operation is helpful. 
  • Knowledge of Quality standards, i.e., QSR & ISO requirements. Good understanding of sampling plan.

Education and Experience

  • Bachelor’s degree in Engineering, Science or related field. 3-5 years of QA experience. Requires scientific and technical knowledge in the areas of manufacturing, laboratory testing, documentation and regulations.

Physical Demands & Working Environment

The physical activity of this position

  • Standing. Particularly for sustained periods of time.
  • Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
  • Hearing. Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.

The physical requirements of this position.

  • Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.

The visual acuity requirements including color, depth perception, and field vision

  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

The conditions the worker will be subject to in this position

  • The worker is subject to atmospheric conditions. One or more of the following conditions that affect the respiratory system of the skin: fumes, odors, dust, mists, gases, or poor ventilation.

 A Career That Matters

Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day. 


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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy


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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