Quality Associate I, Microbiology
$68k - $93.5kBaxter International Inc.
This is where your work makes a difference. 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. Your Role at Baxter This is where your creativity addresses challenges You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Lab Associate, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers. You will primarily support Microbiology Laboratory operations at the Round Lake Manufacturing facility in Round Lake, IL. This position encompasses biological testing support for pharmaceutical products (biologics and drugs) through all stages of the manufacturing process including incoming raw materials, in-process samples and finished product and includes facility environmental and critical systems microbiological monitoring. This is a first-shift Tuesday-Saturday position. Occasional off-shift and holiday work required. What you'll be doing
- Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
- Support improvement projects and drive efficiency through utilization of LEAN management principles (i.e. 5S, Kaizens, etc).
- Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
- Conduct biological testing on raw materials, initial, in-process and final products and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision. Perform sterility or endotoxin testing of final product.
- Conduct routine facility environmental monitoring (i.e. surfaces, air, particulate and personnel monitoring) and critical systems monitoring (water, clean steam, process compressed air and nitrogen).
- Prepare media and reagents used within the laboratory.
- Use laboratory instrumentation (i.e. particle counters, pH meter, SAS, Autoclave) and computer systems (i.e. LIMS) to collect and record data.
- Monitor inventory of supplies, equipment, reagents and media. Order, receive and stock supplies as necessary.
- Perform routine preventative maintenance activities.
- Maintain a clean, safe and organized lab area and perform regular laboratory housekeeping activities.
- Author laboratory investigations and procedures. Perform revisions of laboratory procedures.
- Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
- Prepare data and trend analysis, numerically and graphically, for monthly and quarterly quality system reports.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, QSR and cGMP regulations.
- Follow, understand and comply with Baxter SOP’s and policies on cGMP’s and safety.
- Contribute to other laboratory tasks and projects as assigned.
- Will work in both Drug Delivery and Penicillin facilities as needed.
- Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.
- Bachelors Degree in microbiology or equivalent with biology/microbiology laboratory setting coursework and 0-2 years experience in a laboratory setting.
- Proficient in LIMS (laboratory information management systems).
- Background knowledge in basic Biology and Microbiology principles including aseptic technique is required.
- Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred but not required.
- Ability to handle multiple tasks concurrently and in a timely fashion. Must be detail oriented, conscientious and have high reading comprehension skills.
- Ability to work independently and as part of a team.
- Self-motivation, adaptability and a positive attitude in a highly dynamic environment.
- Ability to lift up to 50 pounds when required.
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