As an Analyst II, QC Environmental Monitoring you will conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at Baxter manufacturing facilities along with Product / Process monitoring, Gas testing and testing of water systems for medical devices through all stages of the manufacturing process from incoming raw materials to finished goods. Support investigations for Microbiology and Environmental monitoring.
What you'll be doing
- Perform routine environmental monitoring for cleanrooms, compressed gas systems and water systems.
- Responsibility for the routine microbiological monitoring of starting materials, finished products and environmental control systems and routine testing where required.
- Generate, review, approve, and maintain microbiological monitoring procedures, laboratory testing documentation, and plant/lab SOPs in compliance with company requirements and applicable FDA, GLP, QSR, and cGMP regulations.
- Perform laboratory and manufacturing audits as required, ensuring data integrity and adherence to SOPs, specifications, and regulatory expectations.
- QC Data entry in Sample manager- BaxLIMS
- Complete routine, special project, and protocol testing in a timely manner.
- Perform or support laboratory equipment maintenance, calibration, qualification, and test method validation activities.
- Support ordering and receiving of purchased media and supplies.
- Perform microbiology and environmental monitoring investigations, data trending, NCRs, CAPAs, and LIRs, serving as the point of contact for departmental updates.
- Communicate professionally and collaborate with internal and external partners to support production, improve efficiency, solve problems, reduce costs, and improve quality.
- Participate in GMP and operational training programs and complete associated training records.
- Maintain the Environmental Monitoring area in a GMP-compliant state while following EHS and 6S guidelines.
- Flexibility to perform other duties, as assigned, or as business needs require.
- Weekend work may be required as needed to meet production timeline schedules.
What you'll bring- B.S. degree in Microbiology, Biology, or related science
- Minimum of 2-3 years of QC Micro experience or equivalent preferably in the pharmaceutical or medical device industry or master’s degree in biological science.
- Strong organizational skills with the ability to manage multiple tasks, meet timelines, and support resolution of technical problems.
- Proficient with basic computer applications, including Microsoft Office, online forms, training systems, performance management tools, and self-service applications.
- Detail-oriented and conscientious, with the ability to read, comprehend, and follow detailed written instructions.
- Proficient in the use of laboratory equipment and tools, with working knowledge of applicable CTPs/SOPs, EHS requirements, FDA/ISO regulations, cGMP, GDP, and chemical/biological safety procedures.
- Ability to read, write, and converse in English, with effective verbal, written, interpersonal, and teamwork skills.
- Knowledge of equipment qualification and test method validation.
- Knowledge of microbiology and environmental monitoring, including LAL, bioburden, growth promotion, and EM testing.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 - $132,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
