Quality Assurance Engineer III

Location
Fremont, California
Posted
Apr 29, 2021
Required Education
Bachelors Degree
Position Type
Full time

Description of Duties:

  • Author or Review validation protocols and reports
  • Perform statistical analysis/hypotheses testing
  • Support CAPA, Deviation, Change Control, and Complaints
  • Reviews executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition
  • Assists in administrating the document control system. Duties include but are not limited to supporting document change control activities, document generation, tracking and distribution for review, approval and filing.
  • Reviews QC data generated from manufactured product, raw materials and intermediates
  • Write/revise/review SOPs for compliance to internal procedures and FDA regulations
  • Independently interacts with other groups to proactively address compliance concerns and resolve problems
  • Perform Software validations
  • May participate on cross-functional compliance improvement projects
  • Lead internal and external audits

 

Position Requirements:

  • BS in Engineering, Chemistry, Biology or other relevant discipline.
  • 4+ years QA or equivalent experience.
  • Prior hands-on experience establishing and/or maintaining electronic compliance systems is required.
  • Strong understanding of cGMP’s and QSR’s
  • Understanding of scientific/technical concepts.
  • Good analytical skills.
  • Clear, concise writing skills and good verbal presentation skills.
  • Excellent organizational skills and attention to detail.
  • Ability to interact constructively and efficiently with co-workers
  • Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Demonstrates strong understanding of procedures and methods for review function.
  • Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • ASQ CQE preferred