Associate III, QA 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. 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.

Summary

The Quality Compliance Associate III will be responsible for non-conformance (NCR) investigations with a focus on those investigations related to Microbiological and Environmental events. This role may also involve other non-conformance investigations for Chemistry and manufacturing events, corrective and preventive actions, revisions to procedures, as well as other related responsibilities. The position reports to the Quality Compliance Manager - Investigations, FAR, and Product Complaints.

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.

What we offer from Day One

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

What you'll be doing

• Review and approve NCR investigations, including a focus on laboratory OOS and OOL investigations, ensuring they are conducted in accordance with established policies and procedures, regulatory requirements, and industry standards, including any department specific requirements

• Ensure timeliness of the investigation and review process, root cause identification adequacy, mitigation and containment strategies, and approval of appropriate corrective actions identified, including effectiveness criteria and timeframe aimed at minimizing or eliminating nonconformance recurrence
• Promotes standardization of investigations within the department and appropriate use of investigative tools to determine root cause of the non-conformance
• Works closely with investigators to facilitate timely closure of investigations and CAPA, while being responsible for meeting product release commitments
• Assist in the development and implementation of Quality Assurance and microbiological strategies, policies, and procedures for the company's manufacturing facilities, including environmental monitoring, microbiological testing, and microbial identification
• Conduct risk assessments and root cause analyses for sterility assurance and microbiology issues and develop corrective and preventive actions to address the root cause determination.
• Understand and apply rigorous quality standards and Current Good Manufacturing Practice (cGMP)

• Participate in regulatory inspections and audits and respond to inquiries and observations from regulatory authorities, as required

What you'll bring

• Bachelor's degree, from an accredited institution, preferably in microbiology, pharmacy, biology, or in a scientific or technical discipline, and a minimum of 3 years in a manufacturing environment in the pharmaceutical, biotechnology, medical device or comparable field. In lieu of the bachelor's degree, 4-8 years of experience in quality control or quality assurance role in a manufacturing environment in the pharmaceutical, biotechnology, medical device or comparable field.
• Strong knowledge of applicable procedures, specifications, regulations and standards. Experience interpreting and complying with cGMP within a pharmaceutical manufacturing environment
• Strong analytical and problem-solving skills with applied experience in root cause determination and utilization of root cause tools
• Experience in performing or reviewing chemistry and / or microbiology laboratory nonconformance investigations is desirable
• Understand verbal and written quality instructions and read and comprehend written work instructions including words and drawings
• Strong knowledge of regulatory requirements and industry standards related to terminal sterilization manufacturing or aseptic processing manufacturing
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and communicate complex technical information to non-technical collaborators
• Experience with regulatory inspections and audits is preferred
• Must be fluent in English written and oral communication skills adequate to communicate with other team members and review documentation

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 $88,000 - $121,000 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.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required.

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

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