New · posted Nov 4
Baxter · Medical Devices
Quality Lab Associate I - Bioburden (7pm-7am)
- Marion, NC
- On-site
- Full-time
- Associate & Specialist
The role
This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
What you need
What you'll bring
- B.S. degree in Microbiology, Biology, or related science
- Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
- Computer literate/knowledge of Microsoft office applications (Word, Excel)
- 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
- Able to communicate effectively with supervisors and peers
- Must be experienced in implementing general microbiology procedures
Skills named in this posting
What you'll do
This is where your creativity addresses challenges
Conduct microbiological analysis on raw materials, solution, and components following approved Standard Operating Procedures in an accurate and timely manner.
- Perform bioburden testing on solution and components (total plate count and spore)
- Process water samples collected by the EM samplers
- Operate lab equipment such as laminar flow hoods, autoclave, incubators, and other equipment
- Perform and document scheduled cleaning and prep activities to include preparation of Spor-Klenz, washing and sanitizing equipment and supplies, discarding used supplies and restocking test materials
- Review samples received, logs samples, and enters data into computer database (LIMS)
- Responsible for general housekeeping of laboratory and test suites
- Sustain a clean and safe work environment utilizing 6S principles
Other Duties as Assigned
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 $68,000-$93,500. 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.
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.
Pay and benefits
$68,000 – $93,500 a year
Employer providedWhat we offer from Day One
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Where you'll work
Marion, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Marion, NCEqual opportunity, accessibility and legal noticesBaxter's statements, word for word
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.
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.
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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% above the US median for Microbiology & Sterility Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $68,000 | — | $93,500 |
| All US (middle half) | $66,000 | $72,500 | $81,000 |
This role: Baxter's own published range. Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 50 open Microbiology & Sterility Assurance roles on Regulatory Jobs, with the titles they carry most. Not Baxter's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods10
- Documentation and SOPs4
- Data and digital systems3
- Collaboration and leadership3
- GMP and compliance1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility Assurance work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ASTMASTM F1980(official source, opens in a new tab)Accelerated aging of sterile barrier systems and medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
Company hiring pulse
Baxter on Regulatory Jobs
- 42
- Open roles
- 38
- Distinct roles
- 11
- Locations
By discipline
- Quality37 88%
- Regulatory5 12%
By level
- Associate & Specialist19 45%
- Manager8 19%
- Senior & Principal7 17%
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Quality Lab Associate I - Bioburden (7pm-7am) at Baxter
Open until filled. $68K–$94K a year, employer provided.