Quality Assoc III
Hayward, CA
Req ID 47006BR
Business Title
Quality Assoc III
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Hayward, CA
Shift_
1st
Job Description
•Responsible for effective implementation of Tier I and Tier II CAPA.
•Represent Baxter CAPA process as Hayward Facility SME.
•Provide CAPA, Lead Investigator Training and other related training to facility CAPA owners and approvers.
•Run, monitor and report on CAPA process at monthly CAPA/Management Review meetings.
•Mentor CAPA and Nonconformance owners.
•Monitor CAPA process to ensure timely, appropriate, thorough resolution of CAPA issues.
•Identify and recommend when CAPA's are needed.
•Ensure final reviews of CAPA records and Closure summaries.
•Attend and actively contribute to monthly division CAPA reps meetings.
•Provide innovative solutions and drive Quality Systems initiatives for continuous improvement, regulatory compliance, nonconformance management and labeling management
•Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities.
•Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
•Be directly involved in and where appropriate lead multiple process/product improvement projects which may include a Kaizen, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
•Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
•Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
•Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
•Must have the ability to perform the responsibilities of the Quality System Manager on an as needed basis
•Assists and writes validations for equipment, product changes and computer systems.
•Assists with audits/assessments and provides ongoing feedback related to quality issues.
Job Requirements
•Understand scientific strategies and be able to invent new methods or new avenues of investigation.
•Good interpersonal/communication/influencing/negotiation skills.
•Good project management skills
•Working knowledge of FDA Regulations and Application of Good Manufacturing Practices. Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering. Interpreting regulations and quality systems. Minimum of 5-8 years of experience in Quality, or related field in the medical products 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.
