Analyst II, Quality ControlReq # JR - 026708 Location Irvine, California, United States Job Category Quality Control Date posted 09/04/2020
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Responsible for execution of specific processes of the plant’s internal quality systems and ensure compliance with regulatory and Baxter requirements. Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements. Provide support to batch release and other quality operations activities.
Essential Duties and Responsibilities:
- Responsible for leading and execution of activities related to product release including batch issuance, review of in-process and final tests, release, sterilization documentation, system maintenance and timeliness/quality metrics associated with the process. Duties include interfacing with supply chain team, coordination and planning of batch release activities.
- Write, review, analyze and revise SOP’s and submit procedural changes as needed to meet Corporate, Plant and Regulatory requirements.
- Support incoming receiving inspection area. Perform activities such as sampling, visual, dimensional and functional tests. Must have ability to be trained on use of equipment to perform quality inspections. Interface with planning and procurement teams to track inbound materials, inspection lead time and meet production demand.
- Support supplier quality related tasks such as performing periodic reviews of records, supplier notifications for quality issues, Supplier Corrective Action Reports (SCAR), agreements, etc.
- Prepare daily reports, monthly, and quarterly summary on quality indicators as required. Support preparation and review of quality data and trends to upper management.
- Ensure quality inspection are properly completed and documented. Act as Subject Matter Expert for quality inspections in areas such as receiving and manufacturing.
- Assist with product containment and hold processes as needed.
- Lead quality initiatives such as defect tracking and trending, maintaining defect libraries and leading awareness training.
- Act as Subject Matter Expert for quality and manufacturing procedures. Continuously identify improvement opportunities related to quality inspection methods.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problems 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, Good Laboratory Practices, and Good Manufacturing Practices.
Education and/or Experience:
- BS in business/science or equivalent degree.
- 3-5 years-experience in Quality with a medical device / Pharma company or other similarly regulated industry.
Physical Demands & Working Environment :
The physical activities of this position:
- Standing. Particularly for sustained periods of time.
- 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.
- 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 discrimination 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 or 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.