Quality Assurance Engineer III

Bayside Solutions
Fremont, CA
15 Jun 2024

Vacancy expired!

Quality Assurance Manager - Fremont, CA

Description of Duties: Author or Review validation protocols and reports Perform statistical analysis/hypotheses testing Support CAPA, Deviation, Change Control, and Complaints 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