Quality Manager II - Validations and Risk ManagementReq # JR - 021854 Location Cleveland, Mississippi, United States Additional Locations 40 Job Category Quality Control Date posted 06/10/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
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About Baxter’s Cleveland, MS Facility:
Cleveland’s technology and automation are cutting edge. It is the U.S. sole source for plastic pour bottles, glass IV, and various reconstitution devices. This facility has a number of major product lines with a diverse array of automated manufacturing technologies ranging from bottle solution filling, injection molding, tubing extrusion, and device assembly. Our Cleveland plant has been an integral part of Baxter for over 60 years. The work is challenging and rewarding, as Baxter offers competitive compensation and benefits. Baxter encourages and values every employee and believes that all can make a contribution to advancing healthcare for patients; work to be proud of.
About the Position:
This position is a key role in the Quality organization. Primary areas of responsibility will be managing activities related with Quality Engineering to provide technical support, and coordinate activities and projects of all documentation and quality operations for areas of responsibility, while assuring compliance with established standards. This key role is responsible for the overall direction, coordination, and evaluation of the unit. This role is responsible for carrying out supervisory duties in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and resolving problems. Additional focus will be on implementing continuous improvement, managing equipment/system upgrades, and new equipment/systems. Cross-functional teamwork and project management will be involved in this role as well. Responsibilities include hardware and software validation, integration of Six Sigma methodology/predictability into plant processes, paperless system implementation, process monitoring (SPC), data integrity requirements, and risk management oversight. The primary end results of this position is to assure all activities carried out through the site are properly executed in accordance with FDA guidelines and meet the overall business priorities and schedules.
Essential Duties and Responsibilities:
- Integrates the Six Sigma Process to Validations, Manufacturing and testing processes.
Assures compliance to all software and hardware validation requirements as well as equipment and software life cycle.
Assures compliance to data integrity initiatives and requirements.
Support timely validation efforts throughout quality operational areas.
Audits, creates, and implements changes to specifications and SOPs.
Plays an active role on quality management teams within the organization.
Supports implementation of VIP projects.
Supports implementation of paperless systems.
Supervise and support all area associates, assuring a teamwork environment.
Trains and integrates new engineers / associates
Oversees training and cross training of direct reports
Evaluates changes to systems and ensures proper process is followed for implementation.
Identify and implement improvements in laboratory testing methods and automation to upgrade laboratory efficiency, consistent with the lowest possible cost objectives of the business.
Leads team in qualification of identified upgrades.
Serves as a team leader to establish working teams.
Maintain good working knowledge of plant systems, processes, procedures, documentation, and products.
Manage and prioritize multiple tasks and projects.
Serve as plant quality software and validation facility contact with corporate or outside interests.
Develop and benchmark new technologies and methodologies for use in the facility.
Promote innovation in quality operational areas
Manage financial goals for departments.
Promote company security, industrial hygiene, cGMPs, and other policies established by the company.
Perform tasks independently with minimum supervision
Travel as needed to perform duties.
Ability to sit, stand and/or walk for long periods of time
Ability to reach above the shoulder
Ability to bend/stoop
Occasionally carry out duties of Quality Director or Operations Manager as needed
Must meet visual acuity requirements as documented in Baxter Cleveland Human Resources Procedure 1.04.
Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly.
- Must perform other duties and responsibilities as determined by supervision/management.
Thorough knowledge of applicable procedures, specifications, regulations and standards.
Strong analytical and problem solving skills.
Ability to manage/supervise a team of employees.
Good communication and leadership skills.
Good interpersonal/communication/influencing/negotiation skills.
Good project management skills.
BS degree in Science or Engineering. 7+ years experience in Quality, Manufacturing, Engineering or related field. 5+ years of leadership experience.Bachelor degree in Microbiology, Biology, Chemistry or Engineering Required.
- Six Sigma Black Belt Certification or industry standard equivalent is preferred.
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.
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Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.