Quality Assoc II
Hayward, CA
Req ID 51321BR
Business Title
Quality Assoc II
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Hayward, CA
Shift_
1st
Job Description
•Ensure timely QA review and release of in-process and finished goods documentation to verify compliance to SOPs and regulatory requirements.
•Write, revise, and review SOPs and/or batch records
•Perform QA on the floor activities (e.g. verifications, inspections, reconciliation, etc.)
•Ensure quality and consistency in documentation and adherence to SOPs.
•Maintain expertise in quality systems (e.g. noconformance management, change control, document control, critical system release, C of A issuance, Control of Nonconforming material, Out of Service, etc) and ability to initiate and execute change control requests.
•Assist with continuous improvement initiatives / projects (e.g. Kaizen)
•Participate in internal or external audits and support audit observations as needed.
•Assist with binding and archiving of lot files.
•Ensure training requirements are met and records are up to date.
•Maintain and update departmental metrics and reporting.
•Work closely with the Manufacturing department to provide on-going Quality support.
•Represent QA at cross-functional meetings, providing QA input and decision making.
•Provide training to group and departments when needed
Job Requirements
Bachelor's degree in Biological Sciences or equivalent . Minimum of 3 - 5 years of experience in Quality and/or equivalent years in GMP environment (Medical Device experience preferred) Must be very detailed oriented with a high quality of work Very knowledgeable in Good Documentation Practices (GDP) Must be a strong team player Working knowledge of FDA regulations (Part 820, 211), ISO 13485, and other applicable regulations. Working knowledge of QC testing (e.g. EM, Microbiology, etc.) Must demonstrate effectiveness in ability to train others, drive results, and meet deadlines. Very proficient in Microsoft Office applications (e.g. Word, Excel, etc) Good interpersonal/communication/influencing/negotiation skills with a strong customer focus. Strong leadership, organizational and time management skills, and ability to handle multiple tasks Experience in Manufacturing operations, a plus ASQ certifications, a plus
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.
