Life Sciences Quality Assurance Engineer

Location
Sunnyvale, CA
Posted
Jul 18, 2019
Required Education
Bachelors Degree
Position Type
Full time

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

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/approve 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
  • Dependability and Quality
  • Productivity and Organizational Skills
  • Teamwork

JSR Micro, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status.