Quality Lab Associate I - Environmental Monitoring (12pm-12am)
Baxter International Inc.
Summary
Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms.
Job description
Your Role at Baxter
Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms.
What you'll be doing
- Conduct microbiological analyses on raw materials, in-process and finished products.
- Use laboratory instrumentation and computer systems to collect and record data.
- Complete all testing, including special project / protocol testing in a timely following local procedures and cGMP regulations.
- Maintain data integrity and ensure compliance with regulatory agencies.
- Operate equipment such as SAS Air Sampler and Climet Particle Counter for the purpose of collecting air/particulate samples.
- Perform surface sample testing using plate and/or swab method.
- Collect water samples throughout the facility on a weekly/monthly basis.
- Perform weekly and monthly HEPA inspections to ensure integrity of HEPA filters in clean-rooms.
- Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean-rooms.
- Perform IMD (Instantaneous Microbial Detection) Testing.
- Review Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval.
- Develop joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor.
- Sustain a clean and safe work environment applying 6S principles.
What you'll bring
- B.S. degree in Microbiology, Biology, or related science.
- Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred.
- Strong communication and project management skills.
- Possess knowledge of core manufacturing and support systems.
- Computer literate/knowledge of Microsoft office applications (Word, Excel).
- Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment.
- Proficient in the aseptic use and handling of media plates and swabs for EM sampling.
- Must be a dedicated individual who requires minimal direction.
- Attention to detail and strong organizational skills.
- Must have a basic understanding of laboratory instrumentation.
- Good documentation skills and knowledge of GDPs (Good Documentation Practices).
- Able to manage multiple tasks/priorities in a timely manner.
- Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology.
- Familiarity with LIMS (or equivalent system) and TrackWise.
- Serve as mentor to Quality Lab Technician (QLT) positions.
- Able to communicate optimally with supervisors and peers
- Knowledge of FDA quality system regulations is preferred.
Requirements
- B.S. degree in Microbiology, Biology, or related science
- Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
- Strong communication and project management skills
- Knowledge of core manufacturing and support systems
- Computer literate/knowledge of Microsoft Office applications (Word, Excel)
- Good interpersonal skills and able to work in a team-based environment
- Proficient in aseptic use and handling of media plates and swabs for EM sampling
- Attention to detail and strong organizational skills
- Basic understanding of laboratory instrumentation
- Good documentation skills and knowledge of GDPs
- Able to manage multiple tasks/priorities in a timely manner
- Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
- Familiarity with LIMS (or equivalent system) and TrackWise
- Knowledge of FDA quality system regulations is preferred
- Applicants must be authorized to work for an employer in the U.S.
Benefits
- Medical, Dental & Vision
- 160 hours Paid Time Off
- Paid Holidays
- 401(k) Matching
- Employee Stock Purchase Program
- Paid Parental Leave
- Tuition Reimbursement
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.