Associate II, Quality

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

Your role at Baxter

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.

Your role at Baxter

• Leads ongoing daily departmental operations.
• May include the supervision of assigned personnel in achieving defined quality goals in an efficient accurate and timely manner; Interview/hire evaluate train and develop direct reports
• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews flow charting and other informational gathering techniques.
• Work closely with production supervisors quality engineering and other internal groups to accomplish the above and influence necessary actions.
• Determine the logic adequacy and effectiveness of processes systems and related requirements.
• Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans.
• Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required assist other Quality areas in the successful performance of these activities.
• Write review analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate Divisional Plant Regulatory Requirements etc.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical analytical and supervisory skills Support process with timely closure of observations/audit items.
• Oversees audits of various reports (Protocols Qualifications Regulatory Submissions etc.) Participate in QA/QC multi-site projects in the role of contributor coordinator or lead.
• Other duties tasks or projects as assigned.
• Sustain a clean and safe work area using 6S principles
• Learn understand and apply rigorous quality standards Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

What you will be doing

• BS in business/science or equivalent. 3-5 years Quality with a medical device/Pharma company or other similarly regulated industry.
• Strong interpersonal skills and great attention to detail are necessary.
• Must be a strong team player with good problem solving and good verbal and written communication skills.
• Must have the ability to manage people encourage teamwork and drive decisions.
• Must be able to handle multiple projects concurrently have computer experience and have knowledge of FDA Regulations Application of Good Laboratory Practices and Application of Good Manufacturing Practices.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

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 $80000 - $110000 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 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.