QA Inspector, LabReq # JR - 022508 Location Irvine, California, United States Job Category Quality Control Date posted 06/10/2020
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Responsible for product quality, efficacy, and safety through the routine assessment of finished products.Responsible for ensuring adherence to the regulatory and procedural requirements that govern those products.
Essential Duties and Responsibilities:
- Conducts final functional/flow testing of final product and documents results in appropriate manner.
- Assists in the initiation of nonconformance documents for product that does not meet specification requirements.
- Promotes continuous improvement through participation on process/quality management teams or in Kaizen events.
- Interacts with appropriate departments to ensure product quality issues are resolved prior to final product release.
- Provide necessary information as required for the failure investigation of defective functional samples from finished goods testing.
- Participate in failure investigation team activities, as required, to address quality issues associated with finished goods.
- Assists in managing test schedules for optimization of testing equipment and resources.
- Knowledge of GMP documentation and FDA regulations.
- High School diploma with 2-4 years experience or Associates with 1 - 3 years related experience or Bachelors with 0-2 years related experience. Experience in a Pharmaceutical or Biotech industry helpful.
Knowledge of GMP documentation and FDA required. Demonstrated attention to details and accuracy, required. Must have good communication skills. General Knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours and overtime on short notice.
Computer Experience required.
The Physical Activity of This Position:
- Reaching. Extending hand(s) and arm(s) in any direction.
- Pushing. Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.
- Lifting. Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. This factor is important if it occurs to a considerable degree and requires substantial use of upper extremities and back muscles
- Fingering. Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling
- Grasping. Applying pressure to an object with the fingers and palm.
- 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.
- Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers.
The physical requirements of this position
- Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
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 hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals. Add from the list
- 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.
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
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Pay Transparency Policy
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.