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Supervisor, Quality Lab – Endotoxin

BAXTER

This is a Full-time position in Asheville, NC posted January 25, 2023.

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. 

Position Summary

Supervise, plan, organize, direct, and evaluate the activities of the Endotoxin and Solution Particulate Matter testing laboratories.

Job Responsibilities
May be required to perform testing when needed and operate lab equipment and instruments
Review and approve data and test results in appropriate system and evaluate data trends
Participate in budget and headcount planning
Review and approve employee time records in Kronos
Write, revise and approve Standard Operating Procedures
Review job-related technical documents and testing

Participates and/or supports internal/external, and regulatory audits as needed
Train others on systems, equipment, procedures as needed
Serve as mentor to other Quality Laboratory positions
Assist in validations for manufacturing processes, laboratory instruments and methods as needed
Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise
Support special projects/protocol testing as needed
Sustain a clean and safe work environment utilizing 6S principles
Assist in the development and execution of department initiatives and KPI’s and effectively achieve team goals and expectations
Assist in the talent development planning of direct reports
Assist Investigators as needed with microbial out of limits investigations
Ensure compliance with all applicable procedures/practices to include global and local SOP’s safety, USP, ISO, cGMP, and applicable regulations

Knowledge, Skills, and Abilities
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Attention to detail and strong organizational skills
Must have a strong understanding of laboratory instrumentation utilized in performing Bacterial Endotoxin testing (Kinetic Turbidimetric Method) and Particulate Matter Testing using Light Obscuration Particle Counters
Good documentation skills and knowledge of GDPs (Good Documentation Practices)
Able to manage multiple tasks/priorities in a timely manner
Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
Working knowledge of LIMS (or equivalent system) and TrackWise
Must be able to communicate effectively with all levels of the organization
Ability to create an environment that values people, encourages trust, teamwork, and open communication through feedback and recognition

Required Education and Experience
B.S. degree in Microbiology, Biology, or related science or Master’s Degree in biological science with minimum of 7 years of experience, preferably in the pharmaceutical or medical device industry
Bacterial Endotoxin Testing Subject Matter Expert
Previous supervisory experience preferred

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 our employees, and we strive to be more transparent with our pay practices.  To that end, this position has a salary range of $60,000 to $132,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position.  The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Other Duties as Assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

#LI-LF1

#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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