Quality Lab Associate III – Sterility Assurance
Job Category: Quality Assurance / Microbiology / Sterility Assurance / GMP Manufacturing
Reference ID: JR-195083
Location: Marion, North Carolina, United States
Company: Baxter International Inc.
Employment Type: Full-Time
Work Authorization: U.S. work authorization required (no visa sponsorship available)
About the Organization
Baxter International Inc. is a global healthcare manufacturer committed to delivering safe, high-quality medical products to patients worldwide. With operations across more than 100 countries, Baxter maintains stringent sterility assurance, environmental monitoring, and contamination control standards to ensure full compliance with global regulatory requirements.
The Quality function is central to Baxter’s mission of saving and sustaining lives, ensuring product safety across the entire lifecycle from manufacturing to distribution.
Position Overview
The Quality Lab Associate III – Sterility Assurance is a senior-level quality and microbiology professional responsible for Environmental Monitoring (EM) qualification activities and contamination control strategy within classified cleanroom manufacturing environments.
This role serves as a Subject Matter Expert (SME) in sterility assurance, leading Environmental Monitoring Performance Qualifications (EMPQ), performing microbiological risk assessments, and supporting regulatory inspections. The position requires deep knowledge of cGMP, cleanroom controls, and microbiological quality systems within regulated pharmaceutical or medical device manufacturing environments.
Key Responsibilities
Environmental Monitoring & Cleanroom Qualification
Author, execute, and complete Environmental Monitoring Performance Qualifications (EMPQ) for classified manufacturing areas.
Perform microbiological assessments to evaluate the impact of operational or facility changes on cleanroom conditions.
Coordinate sampling activities with environmental monitoring teams and manufacturing departments.
Develop response plans for environmental excursions and out-of-limit events.
Sterility Assurance & Contamination Control
Act as SME for contamination control programs and EMPQ processes.
Conduct Failure Modes and Effects Analysis (FMEA) related to microbiological risk.
Perform Sterility Assurance Assessments as part of Change Control Management.
Review and approve EMPQ procedures, protocols, and validation reports.
Ensure adherence to Current Good Manufacturing Practices (cGMP) and regulatory requirements.
Regulatory & Audit Support
Support site audits and regulatory inspections.
Interface directly with regulatory authorities when required.
Ensure documentation and environmental monitoring programs meet regulatory expectations.
Continuous Improvement & Quality Systems
Analyze and present trend reports related to environmental monitoring and contamination control metrics.
Lead continuous improvement initiatives focused on quality, reliability, and operational efficiency.
Author and revise Standard Operating Procedures (SOPs).
Apply Good Documentation Practices (GDP) across quality systems.
Utilize electronic Quality Management Systems, including TrackWise.
Sustain clean and organized laboratory practices aligned with 6S principles.
Training & Leadership
Provide technical guidance to manufacturing and quality teams.
Deliver training sessions for new employees and continuing education programs.
Support cross-functional collaboration across Quality, Manufacturing, and Engineering departments.
Required Qualifications & Experience
Education
Bachelor of Science (BS) degree in Biology, Microbiology, or related life sciences discipline required.
Experience
Minimum 5+ years of professional experience in Laboratory Operations, Quality Assurance, Sterility Assurance, or Manufacturing within a regulated industry.
Strong experience in Environmental Monitoring programs and contamination control strategy.
Experience in pharmaceutical, sterile injectable, or medical device manufacturing environments strongly preferred.
Prior involvement in regulatory inspections and audit readiness initiatives preferred.
Technical Competencies
Strong knowledge of cGMP regulations and sterile manufacturing standards.
Detailed understanding of cleanroom classifications and microbiological control programs.
Experience conducting FMEA and risk-based quality assessments.
Knowledge of TrackWise Quality Management System preferred.
Excellent technical writing and documentation skills.
Ability to manage multiple investigations, projects, and compliance priorities simultaneously.
Core Skills
Analytical and structured problem-solving ability.
Strong communication and leadership capabilities.
Influencing and negotiation skills within cross-functional teams.
Solid project management expertise.
Ability to interpret technical procedures, regulatory standards, and work instructions.
Compensation & Benefits
Estimated Base Salary: USD $80,000 – $110,000 annually (based on experience, qualifications, and location)
Eligibility for discretionary performance bonuses
Medical, dental, and vision coverage starting day one
401(k) with company match
Employee Stock Purchase Program (ESPP)
160 hours of paid time off plus paid holidays
Paid parental leave
Tuition reimbursement and professional development support
Compensation may vary depending on experience level, skills, and market conditions.
Equal Employment Opportunity
Baxter International Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to race, religion, gender, national origin, disability, veteran status, sexual orientation, or other legally protected characteristics.
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