Job Title: Sr QA Inspector, QM Lab
Requisition ID: JR - 183121
Location: Irvine, California, United States
Facility Address: 17511 Armstrong Ave Bldg 3, Irvine, CA 92614
Company Overview – Baxter
At Baxter, we are dedicated to saving and sustaining lives through high-quality products and therapies used worldwide. Our mission connects every team member to the positive impact we create for millions of patients globally. For over 85 years, Baxter has been a pioneer in medical innovations that transform healthcare.
Position Summary
The Sr QA Inspector, QM Lab ensures product and process quality, efficacy, and safety through routine assessment of plant operations and finished products. This role enforces regulatory and procedural compliance across manufacturing and quality systems.
Key Responsibilities
Perform all tasks assigned to a QM Lab Technician with minimal supervision.
Arrange and conduct dose audits of final products with vendors and carriers.
Initiate and investigate exceptions, out-of-limit (OOL) results, and non-conformance reports (NCR) using TrackWise.
Conduct laboratory and manufacturing audits as needed.
Update and maintain plant Standard Operating Procedures (SOPs).
Participate in cross-functional teams to improve production efficiency, quality, and cost savings.
Support continuous improvement projects.
Receive purchased media and supplies for lab use.
Prepare and sterilize reagents, media, tools, and glassware.
Collect test samples in clean rooms and utility areas.
Monitor cleanroom environments, including viable and non-viable air quality and surface conditions.
Monitor environments of critical systems such as compressed air and nitrogen.
Perform microbiological testing on final products, including bioburden and endotoxin tests.
Maintain data integrity and ensure compliance with SOPs and quality specifications.
Document test results accurately using controlled forms or LIMS.
Perform scheduled equipment maintenance.
Qualifications
Knowledge of GMP documentation and FDA requirements.
Strong attention to detail and accuracy.
Good communication skills.
General understanding of quarantine and warehouse operations is helpful.
Willingness to work flexible hours and overtime on short notice.
Experience in pharmaceutical or biotech industries is preferred.
Familiarity with cGMP and FDA regulations is an advantage.
Educational requirements (choose one):
Bachelor’s degree in a science-related field with 0–2 years relevant experience, OR
Associate degree in a science-related field with 1–3 years relevant experience, OR
High school diploma/GED with 5+ years of relevant experience.
Compensation
Base Salary Range: $60,000 – $75,000 annually
(Final offer depends on experience, skills, role tenure, business line, and location.)
Benefits (U.S., Except Puerto Rico)
Medical, dental, and vision coverage starting on Day 1.
Life, accident, short-term and long-term disability insurance.
Business travel accident insurance.
Employee Stock Purchase Plan (ESPP) with discounted stock purchase.
401(k) Retirement Savings Plan with company match.
Flexible Spending Accounts (FSA).
Tuition reimbursement and educational assistance.
Paid holidays and PTO (20–35 days based on tenure).
Paid family and medical leaves.
Paid parental leave.
Commuting and childcare benefits.
Employee discount program and Employee Assistance Program (EAP).
🔗 More about Baxter Benefits
Equal Employment Opportunity
Baxter is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, veteran status, disability status, or other protected characteristics.
🔗 Workplace Discrimination Rights
Reasonable Accommodations
Baxter is committed to providing reasonable accommodations for individuals with disabilities during the application or interview process.
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Recruitment Fraud Notice
Beware of employment scams involving impersonation of Baxter staff. Baxter does not ask for financial or personal information via unofficial channels.
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