Quality Lab Assoc I - EM

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

Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in cleanrooms.

Job Responsibilities

• Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency
• Operate equipment such as SAS Air Sampler and Climet Particle Counter for the purpose of collecting air/particulate samples
• Perform surface sample testing using plate and/or swab method
• Collect water samples throughout the facility on a weekly/monthly basis
• Performs weekly and monthly HEPA inspections to ensure integrity of HEPA filters in cleanrooms
• Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms
• Perform IMD (Instantaneous Microbial Detection) Testing
• Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval
• Fosters collaborative relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor
• Complete testing within required timeframes
• Sustain a clean and safe work environment utilizing 6S principles
• Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise

Knowledge, Skills, and Abilities

• Strong communication and project management skills
• Possess knowledge of core manufacturing and support systems
• Computer literate/knowledge of Microsoft office applications (Word, Excel)
• Must have good interpersonal skills and able to work effectively and efficiently in a team-based environment
• Proficient in the aseptic use and handling of media plates and swabs for EM sampling
• Must be a self-driven individual who requires minimal supervision
• Attention to detail and strong organizational skills
• Must have a basic understanding of laboratory instrumentation
• 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
• Familiarity with LIMS (or equivalent system) and TrackWise
• Serve as mentor to Quality Lab Technician (QLT) positions

• Must be able to communicate effectively with supervisors and peers
• Knowledge of FDA quality system regulations is preferred

Required Education and Experience

• B.S. degree in Microbiology, Biology, or related science
• 0-2 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry 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 $52,800 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.

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.

097894

Qualifications:

Highway 221 North PO Box 1390|Marion, NC 28752|United States of America

Salary : $52,800 - $132,000