Sr Quality Auditor
Hayward, CA
Req ID 50611BR
Business Title
Sr Quality Auditor
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Hayward, CA
Shift_
1st
Job Description
•Maintain Internal Compliance and Supplier Quality Systems in accordance with applicable regulatory requirements.
•Manage the tracking, reporting, dispositioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for all audits performed.
•Prepare for audits/assessments by researching background information, including previous audit results.
•Perform the audit/assessment by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team.
•Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team.
•Manage the assessment file through the process to closure.
•Perform follow-up audits to confirm corrective and preventive action is effective.
•Trains new auditors.
•Participates in the development and delivery of training/refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary
•Keep updated in regulatory trends through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet, or other literature.
•Support and participate with management during external inspections.
•Support Supplier Quality activities, as needed.
•Participate in continuous improvement initiatives such as QLP, Lean, and 6-Sigma.
•Prepares management reports depicting trends and useful data for management review purposes.
•Support compliance improvement initiatives.
•Support plant-wide strategic plan programs and activities.
•May be assigned other duties
Job Requirements
•Excellent communication skills - both written and oral. Able to read, write, speak and understand English.
•Work effectively independently and in team environment.
•Able to work independently and be flexible to changing priorities.
•Resourceful, self-reliant, self-motivated and confident.
•Ability to demonstrate strong organizational skills.
•Must demonstrate sound judgment and analytical skills to enable assessment of risk.
•Extensive working knowledge of applicable quality and regulatory standards and regulations, including GXP regulations and quality management systems.
•Previous auditing experience required. ASQ and/or RAB auditor accreditation is highly desirable.
•Good working knowledge of Windows based applications.
•Working knowledge of related business systems (e.g., Metaphase, Trackwise,).
•Bachelor's degree or equivalent work experience in a scientific or technical discipline.
•Must have 5+ years experience in the areas of GMP regulations that pertain to the business unit.
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.
