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Sr Quality Inspector

Req #: 1800067I_en
Location: Hayward, CA US
Job Category: Quality
Date Posted: 3/20/2018 10:09:02 PM
Baxter International

Description

Summary: Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. 

 

Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of this role that account for the majority of the work. The incumbent will perform other duties assigned.

 * Monitor product quality through the performance of required Visual and Functional Testing. Maintain a working knowledge of statistically based Sampling Plans and their applications. 

* Promote process control through activities in support of equipment and process validations. This includes protocol ownership, paperwork initiation, coordination of manufacturing requirements, performance of required checks, and data analysis through statistical tools and studies. 

 * Monitor processes through the implementation of World Class Manufacturing Strategies, including Statistical Process Control (SPC). Responsible for generating and interpreting SPC control charts. 

* Ensure the accuracy of measuring and testing equipment through the performance of calibrations.

* Perform periodic audits of manufacturing practices and local procedures. Support the corrective and preventive action process by recommending a course of action and coordinating activity during exception situations. 

* Responsible for gathering, analyzing, summarizing, and distributing process relevant data. 

* Promote continuous improvement through participation (i.e. team leader / facilitator or major contributor) in Process Management Team program. 

* Handle customer complaints in timely manner. This includes sample analysis, batch record review, historical trend reviews, root cause identification, and official documentation of findings. 

 

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

* Knowledge of GMP documentation and FDA required. 

 * Demonstrated attention to detail, accuracy and analytical skills required.

* Must have good communication skills and ability to effectively communicate across all departments and levels of management. 

* Must be able to prioritize work responsibilities. 

* General knowledge of quarantine and warehouse operation helpful.

* May be required to work flexible hours and overtime on short notice.  * Must be able to work independently. 

 

Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.

* Bachelor’s degree with 2-4 related experience or Associates degree with 3-5 years related experience or High School diploma with 4-6 years related experience. 

* Experience in a pharmaceutical or Biotech industry helpful.

* Must be familiar with cGMP and FDA requirements. 

* Knowledge of aseptic techniques may be required.

* Must have strong computer / data skills.

Qualifications

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

* Knowledge of GMP documentation and FDA required. 

 * Demonstrated attention to detail, accuracy and analytical skills required.

* Must have good communication skills and ability to effectively communicate across all departments and levels of management. 

* Must be able to prioritize work responsibilities. 

* General knowledge of quarantine and warehouse operation helpful.

* May be required to work flexible hours and overtime on short notice.  * Must be able to work independently. 

 

Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.

* Bachelor’s degree with 2-4 related experience or Associates degree with 3-5 years related experience or High School diploma with 4-6 years related experience. 

* Experience in a pharmaceutical or Biotech industry helpful.

* Must be familiar with cGMP and FDA requirements. 

* Knowledge of aseptic techniques may be required.

* Must have strong computer / data skills.

 

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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