Quality Supervisor, Line Operations (Night Shift)

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 an individual cell within the Manufacturing Quality Assurance team.

This will include such activities as batch review and release, systems release, and nonconformance and CA / PA management while assuring compliance with established standards, regulations, specifications, and SOPs.

Ensure that in process materials, finished products, packaging operations, and 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. NOTE : This is a night shift position Monday through Friday.

Approximate working hours are 5pm to 1 : 30am.

What you'll be doing :

Will interact with manufacturing and supervision daily to address quality process or batch related concerns.

• Performs process compliance audits of all manufacturing areas to assure quality of product / process is achieved.
• Develops, assigns and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures.

Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and efficiency 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 the ability to apply tools to plant scenarios.
• Leads a team of individuals to drive correction, prevention, and improvement throughout the plant. Is responsible for results in terms of timeliness and conformance to regulations and Baxter quality policies.
• Handles documentation and data requests from Pharma clients, division, and product development and support functions related to Quality Management and batch release.
• Maintain appropriate quality metrics for trend analysis and Management Review.
• Balance multiple tasks and projects simultaneously.
• Over see the control and storage of released printed materials and retention samples.
• Assist in external and internal audits by collecting relevant information such as SOP’s and routers.
• Review / approve batch documentation, systems documentation, & perform final batch and systems release.

What you'll bring :

• Must not be allergic to Penicillin or Cephalosporin drugs.
• Bachelor’s degree required, preferably in engineering or science and 3-5 years experience in Quality, Manufacturing / related field OR Associate's degree / High School Diploma and 10+ years experience.
• Must have good solid understanding of plant systems, processes, procedures, documentation, and products.
• Seek new ways to improve and streamline current business and system processes.
30+ days ago