Quality Associate III - Change Control

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

Manage and coordinate routine activities and projects for the facility’s documentation control team, and the plant change control and supplier notice of change programs.  Maintains appropriate quality metrics for trend analysis and reporting to clients and internal management.  Assesses and identifies regulatory and quality risks in activities and processes; conducts gap analyses, implements Quality System policies and procedures, and manages compliance in areas of responsibility. Leads multiple process/product improvement projects. Demonstrates effectiveness in decision-making, problem solving, project management, and team leadership.

What you will be doing:

• Manages facility product/process change control system execution. Change control process owner and TrackWise change control system administrator / subject matter expert. Provide training to plant resources on change control.

• Serves as plant representative and coordinates receipt, evaluation, and response to all Supplier Notice of Change surveys. Supports or leads associated change implementation projects.

• Manages facility documentation control system.  Team lead for documentation control team. System administrator of the TcU document system.  Facilitates the global policies and procedures gap analysis process.  Manages the document change process for plant SOP, procedures, routers, and forms.

• Understands and assures conformance to regulations, and global policies and procedures with respect to change control, supplier notice of change, and documentation control. Conducts gap analyses, implements quality system policies and procedures, and manages compliance in areas of responsibility as plant subject matter expert.

• Manages documentation and data requests from Pharma clients, and corporate product development and other support functions. Maintains appropriate quality metrics for trend analysis and reporting to clients, and facility and corporate management. Analyzes data, develops reports, and presents during Management Reviews.

• Routinely interacts with other corporate groups and external Pharma clients from around the world. Interfaces with inspectors/auditors during regulatory inspections, Pharma client audits, corporate audits, and internal audits.

• Supports continuous improvement and CAPA in area of responsibility. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.

• Supports facility audit ready status efforts for assigned areas and assists other areas within the facility achieve compliance with regulatory and corporate quality system requirements. 

• Supports the operation of the external audit control room operation during regulatory inspections, Baxter corporate audits, and pharma-partner compliance audits.

• Assists in training staff in area of responsibility and assures training requirements are met and records are up to date.

• Assists and writes change control assessments and have the ability to approve other change controls.

• Manage activities of self and direct reports in achieving defined safety, quality, and production goals.

• Assists department in performance of internal compliance audits, collection and analysis of management review metrics, data review, complaint reports, quality escalations, and publishing of annual product reviews

What do you bring:

• Bachelor's degree required, preferably in engineering or science (or equivalent work experience).

• 3 or more years experience in Change Control, Supplier Quality, Quality Assurance, Documentation Control, or QC/QA analysis.

• Must have good working knowledge of plant systems, processes, procedures, documentation, and products.

• Knowledge of global Regulatory and Quality requirements for the manufacture of drugs.

• Exceptional organizational skills and ability to plan and implement resolutions to complex, technical problems.

• Ability to effectively manage multiple, concurrent projects with minimal direct supervision.

• Ability to effectively communicate verbally and in writing with all levels of the organization and with external clients.  Good interpersonal/influencing/negotiation/leadership skills..

• Proficiency with computer-based systems and software such as Microsoft Access, Excel, Word, PowerPoint, TrackWise, TcU, GME, SmartSheets and Adobe Acrobat.

• Must not be allergic to Penicillin or Cephalosporins.

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 and/or long-term 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.

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.

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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.

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