Quality Assoc II
Deerfield, IL
Req ID 50407BR
Business Title
Quality Assoc II
Business
Global Quality
Sub-Business
BioScience BioLife Support
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
To process Quality Systems functions, both through direct responsibility and through the gathering of BioLife center level and BioLife Headquarters' (HQ) quality and regulatory data for routine measurement, analysis, trending and reporting to all levels of BioLife Senior Management.
Utilizing available HQ data sources, this position is responsible for the receipt, assimilation and publication of Quality Systems data, for the Quality/Regulatory Review, Management Review, and/or on an adhoc basis.
This position is responsible for executing these BioLife HQ Quality Systems as defined by assigned role(s):
•Management Review
•Gather and assimilate all BioLife center and HQ data for quarterly Quality and Regulatory Review.
•Prepare presentation of data for quarterly Quality and Regulatory Review and Management Review.
•Administrate the Management Review process
Nonconformance Reporting process (NCR)
•Serve as administrator of the HQ TrackWise NCR Site and Training site.
•Support the HQ NCR Users to ensure timelines are met.
•Prepare routine metrics and reports for distribution.
•Monitor process, analyze metrics for trends and report accordingly.
•Develop corrective and preventive actions as data requires.
•Nonconforming Event process (NCE)
•Administrate the Quality System Department Nonconforming Event process to ensure that timelines are met.
•Prepare routine metrics and reports for distribution.
•Monitor process, analyze metrics for trends and report accordingly.
•Develop corrective and preventive actions as data requires.
•Open Commitment Log (OCL)
•Manage the process and report accordingly
•Quality Systems Department Training
•Administrate and maintain the Quality Systems Department ISOTrain Modules.
•Maintain and develop, as needed, ISOTrain Modules to support existing department systems and processes. Write, revise and review SOP's for all department processes.
Write, review or approve department protocols as required.
Provide quality support of center, department, and headquarters' audits.
Provide support of the following Quality Systems as defined by assigned role(s):
•Contract Review process
•Customer Complaint Review process
•Donor Information System (DIS) Complaint Process
•GSQ - Global Supplier Quality
•IPSO - Interplant Shipping Order
•SCAR - Supplier Corrective Action Report Lead on-going daily departmental activities for areas of direct responsibility, including the project supervision of assigned personnel, and when required, assist other Quality / Regulatory areas in the successful performance of these activities.
The position is be responsible for providing support to the BioLife Headquarters' Management Review, Corrective Action Preventive Action (CAPA) processes, Nonconformance Management (NCR) processes and Nonconforming Event processes.
Must be able to handle multiple projects. Demonstrate effectiveness in task management, decision-making, problem solving, and team leadership.
Other duties and responsibilities as assigned.
Job Requirements
•Exceptional organizational skills and the ability to plan and implement resolutions to problems. Familiarity with interpreting regulations and quality systems.
•Must possess attention to detail and the ability to follow-up on projects to closure.
•Must possess effective interpersonal, communication, leadership, influencing, and negotiating skills to interact with many departments on a frequent basis.
•Working knowledge of FDA Regulations and the application of Good Manufacturing Practices.
•Demonstrated understanding of quality assurance in a FDA regulated environment.
•Demonstrated understanding of plasma center operations - preferred.
•Good project management skills.
•Demonstrated experience with investigational / problem solving tools (DMAIC, Lean) - Certified Lean Green Belt preferred. Required:
Strong computer skills in MS Word, MS Excel, MS PowerPoint, and Access with experience with, ISOTrain, TrackWise and Baxter Quality Tracking System (QTS) desired.
Education/Experience:
Required: Bachelors Degree. Minimum three (3) years experience in a GMP regulated environment (pharmaceutical, medical device, Biotechnology industry).
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
