Quality Associate II

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

The Quality Associate II is responsible for providing Quality support to the Global Logistics Center. Inspects products initiates and updates procedures reviews temperature monitoring data and ensures compliance with GMP/QSRs requirements according to corporate and local Standard Operating Procedures and all applicable FDA and state regulations.

WHAT WE OFFER FROM DAY 1:

• Paid Time Off and Paid Holidays

• Medical Dental Disability and Life Insurance coverage

• Vision and Voluntary Benefits

• Paid Parental Leave

• Retirement Savings Plan

• Employee Stock Purchase Program

• Flexible Health Care Spending Accounts

• Educational Assistance Plan

What youll be doing

• Leads ongoing daily departmental operations of medical devices and drug products local and global distribution.

• Perform indepth internal assessments and evaluations by collecting and analyzing accurate objective evidence regarding risks and their magnitude. Assessments and information gathering may be through indepth employee interviews flow charting and other informational gathering techniques.

• Work closely with supervisors Quality Operations and other internal groups to accomplish the above and influence vital actions.

• 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.

• 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 multisite 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 youll bring

• BS in business/science or equivalent. 35 years exp. in Quality with a medical device/Pharma company or other similarly regulated industry.

• ASQ Certified Quality Auditor or other Quality certification is preferred.

• 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 encourage teamwork and drive decisions.

• Must be able to handle multiple projects concurrently have computer experience and have knowledge of FDA Regulations 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 $80000.00 $111000.00 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. 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.

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.