Location: Round Lake,IL, USA
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
Your role at Baxter
Ensure quality assurance oversight and compliance to approved policies and regulations on laboratory computerized systems and instruments that conduct biological, chemical, and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.
Must not be allergic to Penicillin or Cephalosporin drugs.
What you'll be doing
* Perform administrator functions and maintain user access to laboratory computerized systems and instruments.
* Coordinates training with laboratory personnel for computerized systems and instrumentation after updates and enhancements.
* Understand and maintain knowledge of sophisticated laboratory instrumentation and computer systems used to collect and record data. Understand and maintain knowledge of advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
* Be a Subject Matter Expert (SME) on computerized systems and equipment and know how to troubleshoot issues with laboratory staff.
* Act as a liaison between instrument/plant engineers, IT personnel, validation, and laboratory staff for instrument / system operation.
* Provide input and/or review validation protocols related to laboratory instrument and computerized systems. Assess impact of changes to computerized systems and laboratory instruments.
* Support projects that involves enhancements or updates to computerized systems or new methods which require instrumentation or systems updates to computerized systems. Complete all activities in a timely and appropriate manner.
* Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate nonconformance events and write exception documents.
* Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
* Coordinate with laboratory staff to perform periodic review and laboratory audits. Provide support to audit and update instrument and computerized systems SOPs as required.
* Present information and/or respond to questions during compliance audits.
* Directly involved in and, where appropriate, leads multiple process/product improvement projects which may include any of the following - CAPA Investigations, Complaint, Investigations, Kaizan Teams, Change Control Projects, equipment/process validations, development of new procedures and improving existing procedures, data collection and analysis, report development and presentation.
* Maintains a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and Baxter corporate quality requirements.
What you'll bring
* Bachelor's Degree in Science (Chemistry or Biological science) or technical field (Information Technology or Engineering) with 5 or more years' experience, or Master's Degree with 2 or more years' experience.
* Prior experience with laboratory information management systems and/or laboratory instrumentation is required.
* Experience with BaxLIMS, Empower CDS, LabVantage, Electronic Lab Notebook (ELN), Bacterial Endotoxin Readers, highly desired.
* Strong knowledge of FDA, ISO and GMP regulations.
* Ability to communicate between various levels of engineering, validation, IT, and laboratory personnel.
* Ability to handle multiple tasks concurrently, and in a timely fashion. Occasional off-shift or weekend work may be required.
* Must be able to communicate effectively with managers, peers, and subordinates.
* Strong leadership, organization and time management skills, and ability to manage multiple tasks.
* Must demonstrate effectiveness in ability to train others, empowerment, results oriented and task completion.
* Strong Decision-making and technical problem-solving skills.
* Physical demands of the position may require the ability to lift materials or equipment up to 50 lbs. and wear personal protective equipment.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $76,000 - $104,500 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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 globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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