Quality Lab Associate Ii – Endotoxin

2 years years

$64,000 – $88,000 annually

North Carolina

10 Sept. 8, 2025

Job Description

Job Type: Full Time Education: B.S. in Microbiology, Biology, or related scientific field. 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

🧪 Position Title:

Quality Lab Associate II – Endotoxin
Req #: JR-183793
Location: Marion, North Carolina, United States
Address: 65 Pitts Station Rd, Marion, NC 28752
Shift: Night Shift (7:00 PM – 7:00 AM)

🔍 Position Summary

As a Quality Lab Associate II – Endotoxin, you will conduct microbiological analysis on raw materials, solutions, and water samples in accordance with approved Standard Operating Procedures (SOPs). Your work directly contributes to patient safety by ensuring product sterility and quality through endotoxin and particulate matter testing.

🧩 Key Responsibilities

🧪 Testing & Analysis

Perform endotoxin testing on raw materials, water, and solutions.
Conduct particulate matter testing in accordance with SOPs.
Execute peptidoglycan and gel clot tests as needed.
Monitor and verify daily equipment calibrations (pH meter, balance, pipette, temperature devices).
Manage laboratory reagent inventory and ensure adequate stock.

🔧 Equipment & Maintenance

Calibrate and maintain instruments including:
- Micro-pipettes
- Analytical balances
- Water and dry heat baths
- Depyrogenation ovens
- Spectrophotometers
- Particle counters
Operate laboratory equipment such as:
- Laminar flow hoods
- pH meters
- Endotoxin testing instruments

📄 Documentation & Reporting

Write and revise Standard Operating Procedures (SOPs).
Generate monthly trend reports.
Document results in compliance with Good Documentation Practices (GDP).
Utilize systems such as LIMS, POMS, Endoscan-V, Sampler Sight Pharma, and AS400.

🛠 Quality & Compliance

Participate in audits and internal inspections.
Serve as a mentor to Quality Lab Associate I team members.
Provide backup support to QLA III roles.
Write exceptions, nonconformance reports (NCRs), and CAPAs using TrackWise.
Maintain a clean, safe, and organized work environment using 6S principles.

🎓 Qualifications

Education:
- B.S. in Microbiology, Biology, or related scientific field.
Experience:
- Minimum 2 years in pharmaceutical or medical device industry;
- OR Master’s degree in biological sciences with hands-on lab experience.
Skills & Knowledge:
- Strong understanding of cGMP, GLPs, and USP microbiological testing methods.
- Familiarity with aseptic sampling/testing techniques.
- Excellent documentation and communication skills.
- Ability to prioritize and multitask in a fast-paced environment.
- Comfortable standing for long periods and lifting up to 50 lbs.

💼 Compensation & Benefits

Estimated Base Salary: $64,000 – $88,000 annually
Final compensation is based on experience, skills, and location.
May be eligible for discretionary bonuses.

✔ Benefits from Day One:

Medical, Dental, Vision insurance
401(k) with company match
Employee Stock Purchase Plan (ESPP)
160 hours of Paid Time Off + Paid Holidays
Paid Parental Leave
Tuition Reimbursement
Childcare & commuting benefits
Flexible Spending Accounts
Employee Assistance Program (EAP)
Employee Discounts

🔗 For full benefit details: Baxter Benefits Site

🌎 Baxter's Mission & Culture

Baxter’s global mission is to save and sustain lives. Our culture values:

Courage
Trust
Collaboration
Accountability
Continuous improvement
A commitment to Quality over Quantity

You'll be part of a team that encourages speaking up, learning, and taking ownership. Your work will directly impact patients across the world.

⚖️ Equal Opportunity Employment

Baxter is an Equal Opportunity Employer. We evaluate all applicants based on merit, regardless of race, color, religion, gender, age, sexual orientation, veteran status, disability, or any other legally protected status.

🔗 Know Your Rights: Workplace Discrimination is Illegal

♿ Reasonable Accommodations

Baxter is committed to accommodating applicants with disabilities.
If you require assistance during the application or interview process, request accommodations here.

⚠️ Additional Notes

Applicants must be authorized to work in the U.S.
Baxter does not provide sponsorship for employment visas.
Overtime may be required.
Job duties may change at any time with or without notice.

❗ Recruitment Fraud Alert

Beware of scams where individuals impersonate Baxter recruiters to steal personal or financial information.
🔗 Learn more: Recruitment Fraud Notice

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Quality Lab Associate Ii – Endotoxin

Job Description

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