Analyst II, QC Environmental Monitoring

Baxter International Inc.•Winton, CA

2d•$96,000 - $132,000•Onsite

About The Position

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. 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.

Requirements

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.

Responsibilities

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.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits