• Quality Associate II - Manufacturing Quality Assurance Jobs in United States Of America

  • Baxter India Pvt Ltd
  • United States Of America, Usa

Job Description:

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 Were 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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Summary

Manage and coordinate routine activities and projects for an individual cell within the second shift 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

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

Will interact with manufacturing and supervision on a daily basis to address quality process or batch related concerns
Performs process compliance audits of all manufacturing areas to ensure quality of product/process is achieved
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 the ability to apply tools to plant scenarios
Manages 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
Manages documentation and data requests from Pharma clients, division, and product development and support functions related to QM Manufacturing Quality Assurance and batch release
Maintains appropriate quality metrics for trend analysis and Management Review
Must have good working knowledge of plant systems, processes, procedures, documentation, and products
Plays an active role on quality management teams within the organization
Must be able to manage multiple tasks and projects simultaneously
Manage activities of self and Technicians in achieving defined safety, quality, and production goals
Manages the control and storage of released printed materials and retention samples
Should be able to communicate at all Plant and Divisional levels
Assist in external and internal audits by collecting relevant information such as SOPs and routers
Performs process compliance audits for areas of responsibility
Review and approve batch documentation
Review and approve systems documentation
Perform final batch and systems release

Qualifications

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

Qualifications - External

Job Requirements (Education, Experience)

Bachelors degree required, preferably in engineering or science 3-5 years experience in Quality, Manufacturing or related field

Qualifications

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

Ability to 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 manage/supervise a team of employees Ability to contribute to and lead project teams
Must be able to lift 30 pounds Must not be allergic to Penicillin or Cephalosporin drugs
Knowledge of JDE, GME and Trackwise a plus

Physical / Safety Requirements

Duties may require overtime work, including nights and weekends

Use of hands and fingers to manipulate office equipment is required

Position requires standing and walking for extended periods of time

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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Reasonable Accommodations

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_TTAbaxtercom and let us know the nature of your request along with your contact information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Company
Baxter India Pvt Ltdarfix

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