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Quality Assurance Manager
2 months ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Baxter. As a key member of our Manufacturing Quality Assurance team, you will be responsible for ensuring the quality and safety of our products and processes.
Key Responsibilities- Manage and coordinate routine activities and projects for an individual cell within the Manufacturing Quality Assurance team.
- Perform process compliance audits of all manufacturing areas to assure quality of product/process is achieved.
- Develop, assign and implement systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures.
- Apply 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.
- Lead a team of individuals to drive correction, prevention, and improvement throughout the plant.
- Handle 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.
- Oversee 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.
- 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.
- Must not be allergic to Penicillin or Cephalosporin drugs.
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 $60,000-$82,500 annually.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
