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

Manage and coordinate routine activities and projects for the documentation center/batch release team. This will include such activities as batch review and release systems review and release and nonconformance and CA/PA management while assuring compliance with established standards regulations specifications and SOPs. Ensure that batch record documentation is in compliance with internal corporate/division/plant quality control programs current Good Manufacturing Practices current Good Documentation Practices and external regulations. Assure the safety and quality of the products processes and systems.

***The candidate must not be allergic to penicillin or cephalosporin ***

What youll be doing

• Review and approval of batch and systems documentation.
• Develops assigns and implements systems procedures and policies to assure compliance with cGMPs and FDA regulations and company policies and procedures. Assess all plant systems operations products processes procedures and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CA/PA.
• Applies problem solving logically and in an organized manner. Must have experience with Root Cause Analysis tools and applying tools to plant scenarios.
• Manages documentation and data requests from Pharma clients division Global Business Unit and product development and support functions related to QM Manufacturing Quality Assurance and batch release.
• Maintains appropriate quality metrics for Management Review.
• Will interact with manufacturing and supervision daily to address batch related concerns.
• Must have good working knowledge of plant systems processes procedures documentation and products.
• Plays an active role on quality management teams within the organization.
• Handle multiple tasks and projects simultaneously.
• Considered a team lead for Technicians in achieving defined goals.
• Communicate at all Plant and Divisional levels.

What youll bring

• Bachelors degree required preferably in engineering or science.
• 3 or more years experience in Quality Manufacturing or related field.
• Drives efforts to identify and implement process efficiencies in order to achieve established release goals.
• Seeks new ways to improve and streamline current business and system processes. Identifies manages and where appropriate leads multiple process/product improvement projects with the objective of achieving quality efficiency and cost improvements.
• Works with minimal supervision.
• Communicate efficiently verbally and in writing with all levels of the organization and with external clients. Good interpersonal/influencing/negotiation/leadership skills.
• Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Good project management skills.
• Thorough knowledge of applicable regulations and standards. Strong analytical/problem solving skills.
• Ability to supervise a team of employees and lead project teams.
• Must lift 30 pounds.
• Knowledge of JDE GME Trackwise Labvantage/Laboratory LIMs and IDBS EWorkBook a plus

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 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

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