Quality Lab Associate I

3 weeks ago

Round Lake, United States BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

**Your Role at Baxter**:** This is where your creativity addresses challenges**

The Quality Lab Associate encompasses the biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.

This is a 3rd shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required.

**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.

**What you'll be doing**:

- Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities. Work under minimum supervision.
- Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC, etc.) and computer systems to collect and record data.
- Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
- Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
- Perform equipment maintenance and calibrations as required.
- Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records.
- Follow, understand, and comply with Baxter SOP’s and policies on cGMP’s and safety. Maintain a clean, safe, and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas.
- Investigate deviations and write exception/OOL/OOS/OOT documents.
- Support improvement projects and drive efficiency through utilization of LEAN management principles (i.e., 6S, Kaizen, etc.).
- Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
- Maintain and meet the highest standards in quality, customer service and regulatory compliance.
- Other projects as assigned.

**What you'll bring**:

- Bachelor’s degree in chemistry or science-related degree with 6 months or more of experience.
- Knowledge of Empower Chromatography Data Systems and LIMS is preferred but not required.
- Knowledge of GLP, cGMP requirements and familiarity with USP/ICH guidelines is preferred but not required.
- Excellent communication (oral and written) and interpersonal skills.
- Ability to work independently and as part of a team, self-motivated, demonstrates adaptability, and possesses a positive attitude in

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