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 Company
Baxter International Inc. is a global healthcare leader dedicated to improving patient outcomes through high-quality medical products and sterile manufacturing solutions. Operating in more than 100 countries, Baxter maintains rigorous sterility assurance and contamination control programs to ensure product safety and regulatory compliance across global markets.
The Quality organization plays a critical role in protecting patient safety, maintaining GMP compliance, and driving continuous improvement throughout manufacturing operations.
Position Overview
The Quality Lab Associate III – Sterility Assurance serves as a Subject Matter Expert (SME) in Environmental Monitoring (EM) and Contamination Control within controlled and classified cleanroom environments. This role is responsible for leading Environmental Monitoring Performance Qualifications (EMPQ), sterility assurance assessments, and microbiological risk evaluations to ensure compliance with cGMP and regulatory standards.
This opportunity is ideal for experienced microbiology or sterility assurance professionals seeking a senior-level laboratory and compliance role within a regulated medical device or pharmaceutical manufacturing environment.
Key Responsibilities
Environmental Monitoring & Cleanroom Qualification
Author, execute, and complete Environmental Monitoring Performance Qualifications (EMPQ) for classified manufacturing areas.
Conduct microbiological assessments to evaluate the impact of changes on cleanroom conditions.
Coordinate EM sampling activities with manufacturing and quality teams.
Establish response plans for environmental monitoring excursions and out-of-limit events.
Sterility Assurance & Contamination Control
Serve as SME for contamination control programs and EMPQ strategies.
Perform Sterility Assurance Assessments within the Change Control Management process.
Conduct Failure Modes and Effects Analysis (FMEA) related to microbiological risk.
Ensure alignment with current Good Manufacturing Practices (cGMP) and global regulatory expectations.
Regulatory & Audit Support
Support regulatory inspections and site audits.
Interface directly with regulatory authorities during inspections.
Review and approve EMPQ procedures, protocols, and reports.
Ensure documentation meets regulatory, internal, and quality system requirements.
Data Analysis & Continuous Improvement
Prepare and present trend reports related to environmental monitoring and contamination control.
Lead quality and reliability improvement initiatives.
Identify and implement cost-effective quality enhancements.
Sustain a clean and safe work environment using 6S principles.
Documentation & Training
Author and revise Standard Operating Procedures (SOPs).
Apply Good Documentation Practices (GDP).
Deliver classroom-based training for new and existing employees as required.
Utilize electronic Quality Management Systems such as TrackWise.
Required Qualifications & Experience
Education
Bachelor of Science (BS) degree in Biology, Microbiology, or related life sciences discipline required.
Professional Experience
Minimum 5+ years of professional experience in Laboratory, Quality Assurance, Manufacturing, or Sterility Assurance within a regulated industry.
Experience in medical device, pharmaceutical, or sterile manufacturing environments strongly preferred.
Demonstrated expertise in Environmental Monitoring programs and microbiological contamination control.
Experience supporting regulatory inspections and audits.
Technical Competencies
Strong knowledge of cGMP and regulatory standards.
Detailed understanding of cleanroom classification and monitoring strategies.
Familiarity with FMEA and risk-based quality methodologies.
Knowledge of Quality Management Systems (QMS), including TrackWise preferred.
Strong technical writing and documentation skills.
Ability to manage multiple projects and investigations simultaneously.
Core Skills
Analytical problem-solving capability.
Strong interpersonal and communication skills.
Leadership and influencing abilities.
Project management proficiency.
Ability to interpret technical procedures, specifications, and regulatory documentation.
Compensation & Benefits
Estimated Base Salary: USD $80,000 – $110,000 annually (based on experience, skills, and location)
Potential eligibility for discretionary performance bonuses
Medical, dental, and vision coverage from 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 programs
Compensation may vary depending on qualifications, market conditions, and experience level.
Equal Employment Opportunity
Baxter International Inc. is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, religion, gender, national origin, age, disability, veteran status, sexual orientation, or other legally protected characteristics.
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