Quality Associate I Compliance

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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters 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

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 Team at Baxter

Within Quality every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether its building a new process from scratch or facing a neverbeforeseen 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.

What Youll Be Doing

• Leads ongoing daily departmental operations.

• May include the supervision of assigned personnel in achieving defined quality goals in an efficient accurate and timely manner. Provide direct supervision of assigned individuals including mentoring development performance management and staffing decisions.

• 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. Determine the logic adequacy and effectiveness of processes systems and related requirements. Develop plans to correct identified risks including areas of nonconformance inform management and implement approved corrective action plans.

• Write review analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet all necessary requirements.

• Support external assessments or audits.

• Assist with audits of various reports (Protocols Qualifications Regulatory Submissions etc.

• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant areas.

What Youll Bring

• Associate degree in business/scientific discipline.

• Bachelors degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.

• 13 years of relevant experience.

• Strong interpersonal skills and great attention to detail are necessary.

• Must be able to handle multiple projects concurrently.

• Have strong knowledge of FDA Regulations Application of Good laboratory Practices and Application of Good Manufacturing Practices.

• 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.

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.

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 $64000 $88000 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 commission and/or longterm incentive. 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.

#LILS1

US Benefits at Baxter (except for Puerto Rico)

This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm 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 timeoff 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.