Life Sciences Quality Assurance Engineer 2 9/17/2017
JSR Micro, Inc.
JOB DESCRIPTIONAPPLY DUTIES AND RESPONSIBILITIES
Review, setting and updating of internal specs - internal teams, global subsidiaries and partners
Customer related quality questionnaires - developing templates reflective of our global business
Create internal documents and procedures to meet JSR quality standards and customer requirements
Operations - product release - Release of products entering Sunnyvale - gatekeeper of product release process - Handle quality related questions and issues
Advise quality requirements and compliance to meet customer requirements
Support product development efforts as a quality representative through product launch
review of Regulatory Support File
review of product manufacturing and raw material supplier
Conduct third party audits
Lead and develop harmonization plan for unified global QMS of current and future partners
Develops and implements processes, procedures, forms, metrics and tools for quality systems.
Reviews and revises/approves quality and validation documents.
Experience in change control, non-conformance investigations, new material and batch release, quality systems auditing and validation review.
Conducts training for Life Sciences, Bioprocess and IVD teams in quality systems processes to ensure adherence
Communication & Interpersonal Skills
Self-Management & Organizational Skills
Collaboration & Teamwork
Project Management & Planning
Continuous Quality and Process Improvement
Creative & Innovative with a Customer Focus