Life Sciences Quality Assurance Engineer 2 - Sunnyvale, CA | Biospace
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Life Sciences Quality Assurance Engineer 2

JSR Micro, Inc.

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Location:
Sunnyvale, CA
Posted Date:
9/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Engineering, Quality Assurance,

Job Description


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


KEY COMPETENCIES

•   Communication & Interpersonal Skills

•   Job Knowledge

•   Self-Management & Organizational Skills

•   Collaboration & Teamwork

•   Problem Solving

•   Project Management & Planning

•   Continuous Quality and Process Improvement

•   Creative & Innovative with a Customer Focus

Requirements


EDUCATION

BS/MS in Life Sciences (Biology, Biotechnology, Bioscience, Biochemistry) or a related discipline

SKILLS & EXPERIENCE      

•   Prefer a minimum of 3-5 years of experience as a skilled engineer specializing in quality assurance with proven experience in validation and/or compliance role in a bioprocess industry
•   Requires intermediate skills in MS Office, SPC software, knowledge of ISO standards, and document control software

•   QA and QMS experience

•   Experience in development of GMP systems

•   Experience with FDA/regulatory audits desired.

•   Understanding of FDA 21 CFR, ISO9001 requirements and how it applies to crucial raw material vendors

•   Works on assignments requiring considerable judgment and initiative; understands implications of work and makes recommendations for solutions

•   Excellent verbal and written communication skills

•   Project management experience/ organizational skills

•   Ability to work across departments, business units, and global cultures with a broad scope

•   Working knowledge of descriptive statistical techniques