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Assoc III, Quality

Req #: 180008A4_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 4/10/2018 11:30:48 AM
Baxter International

Description

Quality Associate III Line Operations

 
Summary:
Manage and coordinate routine activities and projects for an individual cell within the quality line operations 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:
  • Quality Line Lead for Quality Technicians.
  • 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 cGMP's 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 Line Operations 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.
  • Financial responsibilities and accountabilities to include department and capital budgeting and expenditures for areas of responsibility.
  • Initiate Quality Holds when necessary.
  • 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
  • Interfaces with a during regulatory audits, Pharma client audits, corporate audits, internal audits.
  • 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

***  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 team.
  • 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
 

Education and/or Experience:

  • Bachelor’s degree in Science or Engineering required

  • 5-8 years experience in Quality, Engineering or related field.

  • 2-3 years of experience in auditing techniques, interpreting regulations and quality system helpful.

  • Strong technical writing skills. Must be able to clearly document audit findings within audit reports.

  • Strong technical, analytical and problem solving skills.

  • Good interpersonal, communication, influencing, negotiation skills.

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