🧪 Job Title:
Quality Lab Associate III - Investigations (7am-3pm)
Req #: JR - 183298
Location: Marion, North Carolina, United States
🌟 About the Role
As a Quality Lab Associate III - Investigations, you will lead microbial out-of-limit investigations, determine root causes, and develop corrective and preventive actions (CAPAs) to ensure product quality and patient safety. You will collaborate across departments including Quality, Operations, Engineering, Maintenance, and Supply Chain to manage investigations efficiently and compliantly.
📋 Key Responsibilities
🔍 Investigation Leadership
Lead investigations of microbial out-of-limit events, determining scope, product impact, and root cause.
Define and implement effective corrective and preventive actions (CAPAs) to prevent recurrence.
Assemble cross-functional teams and conduct interviews and observations to gather facts.
Manage multiple investigations simultaneously and close investigations timely to meet business and compliance requirements.
Work independently to drive investigations to closure.
🤝 Collaboration & Communication
Foster collaborative relationships focused on high-quality, timely investigations and CAPA execution.
Communicate investigation status and results to stakeholders at all levels.
Present and defend investigations during regulatory inspections as required.
📑 Documentation & Compliance
Manage investigation and CAPA documentation in TrackWise, ensuring compliance with Baxter practices and procedures.
Understand and implement procedures supporting CAPA execution.
Maintain thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
🎓 Qualifications & Skills
📚 Education & Experience
Bachelor’s or Master’s degree in science, preferably Microbiology.
Minimum 2 years of experience conducting root cause investigations in pharmaceutical or medical product industries.
Minimum 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality.
🧠 Technical Skills
Thorough understanding of pharmaceutical/medical device manufacturing and regulatory requirements (FDA quality systems regulations).
Knowledge of problem-solving methodologies (e.g., DMAIC).
Proficient in technical writing, able to clearly communicate complex issues.
Working knowledge of TrackWise or equivalent quality management systems.
🗣️ Soft Skills
Strong communication, interpersonal, and project management skills.
Ability to influence and interact with personnel at various organizational levels.
💵 Compensation
Estimated Annual Salary Range: $80,000 - $110,000
Pay varies based on location, experience, skills, and other factors.
May be eligible for discretionary bonuses.
🎁 Benefits (U.S. Employees)
Medical, Dental, and Vision coverage starting day one.
160 hours of Paid Time Off plus Paid Holidays.
401(k) retirement plan with company match.
Employee Stock Purchase Program.
Paid Parental Leave.
Tuition Reimbursement.
Additional benefits: Flexible Spending Accounts, Employee Assistance Program (EAP), childcare support, commuting benefits, Employee Discount Program.
🔗 Explore Baxter Benefits
⚖️ Equal Opportunity & Legal Notices
Baxter is an Equal Opportunity Employer.
Applicants considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, disability, or other protected status.
🔗 Know Your Rights: Workplace Discrimination is Illegal
♿ Accommodations
Reasonable accommodations are available for individuals with disabilities.
Requests can be made during the application or interview process via Baxter’s accommodation request link.
⚠️ Recruitment Fraud Warning
Baxter warns against fraudulent job scams impersonating Baxter recruiters.
Baxter never requests personal or financial information during recruitment.
🔗 Recruitment Fraud Notice
✅ Additional Information
Applicants must be authorized to work in the U.S.
Baxter does not sponsor employment visas at this time.
📍 Location
65 Pitts Station Rd
Marion, NC 28752
United States of America
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