Principal Associate - Microbiology

5+ years

$88,000 – $121,000

United States

10 Oct. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Principal Associate – Microbiology

Req ID: JR - 183084
Location: Marion, North Carolina, United States
Job Category: Quality (Microbiology / Sterility Assurance)
Date Posted: —

Overview:

This is where you make a difference in patients’ safety.

As a member of the Baxter Quality team, you’ll play an essential role in our mission to save and sustain lives. Quality at Baxter spans the entire product lifecycle, working collaboratively across all departments. Because Quality touches everything Baxter does, this role offers continuous learning, growth, and the opportunity to have a direct impact on patients’ lives.

Why Join Baxter Quality:

Support for Parents
Continuing Education & Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Volunteer Days per Year

Success Profile – What Makes a Great Fit

A successful Baxter Quality professional is:

Detail-Oriented
Continuously Learning
Courageous
Collaborative
A Critical Thinker
Influential

Your Role at Baxter:

This is where your creativity addresses challenges.

The Principal Associate – Microbiology is responsible for managing activities and continuous improvement projects that enhance contamination control of the manufacturing facility, cleanrooms, and processes. The role includes project management, coordination, and SME (Subject Matter Expert) support in sterility assurance and contamination control.

Your Team at Baxter:

Within Quality, every role contributes to ensuring that Baxter’s products meet the highest standards for patients worldwide. Whether creating new processes or solving production challenges, every individual is empowered to apply creativity and excellence.
At Baxter, quality always comes first—because patients come first.

What We Offer (From Day One):

Medical, Dental, and Vision Coverage
160 Hours of Paid Time Off + Paid Holidays
401(k) Match
Employee Stock Purchase Program (ESPP)
Paid Parental Leave
Tuition Reimbursement

What You’ll Be Doing:

Support and implement large-scope projects.
Provide Sterility Assurance SME support across departments and teams.
Ensure project designs align with Annex I, ISO 14644-1, and other global standards.
Lead continuous improvement projects focused on contamination control.
Apply problem-solving tools (CAPA, root cause analysis) to improve quality.
Provide microbiological expertise for SOPs, change controls, and validations.
Design and deliver training programs for cleanroom behavior and contamination control.
Author, review, and approve environmental cleaning protocols and efficacy studies.
Conduct environmental FMEAs and risk assessments for facility/process changes.
Assess and control contamination risks during construction or renovation activities.
Maintain site contamination control practices and train personnel on the floor.
Influence operations to identify and correct quality compliance issues.
Author and revise SOPs for CAPAs and continuous improvement initiatives.
Act as SME during regulatory inspections (FDA or international agencies).
Mentor and train junior colleagues in Sterility Assurance.
Uphold 6S principles for a clean and safe work environment.
Apply rigorous quality standards, SOPs, and cGMP principles consistently.

What You’ll Bring:

Education:
- Bachelor’s degree in Microbiology, Biology, or a related life science field.
Experience:
- Minimum 5 years in the Pharmaceutical or Medical Device industry, primarily in Sterility Assurance.
- Microbiology lab background strongly preferred.
Technical Expertise:
- Strong knowledge of aseptic technique, cleanroom behavior, and contamination control.
- Familiarity with environmental monitoring, bioburden, and endotoxin testing.
- Advanced understanding of FDA cGMP, EU Annex 1, and ISO 14644-1 standards.
- Experience with quality systems, CAPA, and validation processes.
- Excellent technical writing and data analysis skills.
Soft Skills:
- Strong communication, leadership, and project management skills.
- Ability to work across multiple departments and hierarchical levels.
- Proficiency in English (oral and written).

Compensation:

Estimated Base Salary: $88,000 – $121,000 annually
Pay may vary based on skills, experience, and location
May include discretionary bonuses

Additional Information:

Applicants must be authorized to work in the U.S.
Visa sponsorship not available
#LI-EB1
Other duties as assigned (including overtime if required)

U.S. Benefits at Baxter (except Puerto Rico):

Your well-being matters. Baxter provides:

Medical & Dental coverage (Day 1)
Life, Accident, Short-/Long-Term Disability Insurance
401(k) + Company Match
Employee Stock Purchase Plan (ESPP)
Flexible Spending Accounts (FSA)
Educational Assistance
20–35 days Paid Time Off (based on service)
Paid Parental Leave
Commuter & Childcare Benefits
Employee Assistance Program (EAP)
Employee Discount Program

🔗 Visit: Baxter Benefits

Equal Employment Opportunity:

Baxter is an Equal Opportunity Employer and prohibits discrimination based on race, color, religion, gender, age, sexual orientation, gender identity, veteran status, disability, or any legally protected trait.

📜 Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations:

Baxter provides reasonable accommodations for applicants with disabilities during the hiring process. Contact Baxter with details of your request and contact information.

Recruitment Fraud Notice:

Baxter has identified employment scams involving fraudulent recruiters posing as Baxter representatives. Baxter recruiters will never request personal or financial information during the application process.
Learn more at Baxter’s Recruitment Fraud Notice.

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Principal Associate - Microbiology

Job Description

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