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Quality Laboratory Associate III

Baxter Healthcare

Round Lake (IL)

On-site

USD 80,000 - 110,000

Full time

24 days ago

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Job summary

An established industry player in medical equipment seeks a Quality Laboratory Associate III to conduct vital analyses on pharmaceutical products. This role involves working with advanced laboratory instrumentation, mentoring junior staff, and ensuring compliance with stringent quality standards. The ideal candidate will possess a Bachelor's degree in Chemistry or a related field, with strong analytical and communication skills. Join a mission-driven team dedicated to improving patient outcomes and making a positive impact on lives worldwide. If you're ready to contribute to meaningful work in a dynamic environment, this opportunity is for you.

Benefits

Medical and Dental Coverage
401(k) Retirement Savings Plan
Employee Stock Purchase Plan
Flexible Spending Accounts
Educational Assistance Programs
Paid Time Off
Childcare Benefits
Employee Assistance Program

Qualifications

  • 5+ years of experience in laboratory analysis.
  • Knowledge of cGMP and GLP regulations preferred.
  • Ability to train and mentor junior staff.

Responsibilities

  • Conduct chemical and physical analysis on pharmaceutical products.
  • Perform qualification and validation activities for lab equipment.
  • Ensure compliance with FDA, GLP, and cGMP regulations.

Skills

Analytical Skills
Communication Skills
Problem-Solving Skills
Attention to Detail
Ability to Work Independently

Education

Bachelor's Degree in Chemistry or Physical Science

Tools

HPLC
GC
LIMS
Empower Chromatography Data Systems

Job description

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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

The Position encompasses 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 first shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required.

The candidate must not be allergic to Penicillin, Cephalosporins, or their related products and /or materials.

What you'll be doing

  • Conduct critical chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at the Round Lake manufacturing facility.
  • Perform qualification/validation activities for laboratory equipment and computer systems.
  • Work under minimal to no supervision.
  • Serve as mentor to Quality Laboratory Associate (QLA) I and II positions.
  • Provide training and work direction for new hires.
  • Perform review of test data, which includes overall documentation practices.
  • Perform release functions in LIMS or other computerized systems.
  • Use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems to collect and record data.
  • Be a Subject Matter Expert (SME) on equipment and know how to troubleshoot issues.
  • Perform advanced chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner.
  • 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.

What you'll bring
  • Bachelor degree in Chemistry or physical science with 5 or more years of experience.
  • Must have good oral and written communication skills, strong analytical skills and be detail oriented.
  • Knowledge of current Good Manufacturing Practices is preferred.
  • Advanced laboratory skills with basic knowledge of statistical methods.
  • Strong technical problem solving skills.
  • Ability to handle multiple tasks concurrently, and in a timely fashion.
  • Knowledge of Empower Chromatography Data Systems and LIMS is preferred but not required.
  • Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required.
  • Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion.
  • Ability to work independently and as part of a team, is self-motivated, demonstrates adaptability, and possesses a positive attitude in a highly dynamic environment.
  • Ability to lift up to 50 pounds when required.
  • Occasional weekend work required.
  • Must not be color blind.
  • Must not be allergic to penicillin or cephalosporin drugs.

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 $80,000 - $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon 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: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Research, Analyst, and Information Technology
  • Industries
    Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health Care

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