43 QA Associate Jobs in Bothell, WA
TSR Consulting Services, Inc is Hiring a QA Associate Near Bothell, WA
Job ID #: 79757Work Location: Bothell, WA – 100% on site
SummaryMaintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.
Knowledge/Skills
- Documentation Review experience
- Scientific Degree
- Experience working in a GMP environment
- B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred.
- 2 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
- Knowledge of biotech product manufacturing.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of Oracle, BMRAM, MES, Veeva Infinity are a plus
- Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
- Inspects and releases intermediates or packaged drug product per specifications.
- Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
- Drafts and reviews specifications and SOPs.
- Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
- May provide guidance to less experienced staff.
- Provides sitewide support during daily walkthroughs of GMP areas.
The post QA Associate appeared first on TSR Consulting Services.
Job Summary
Full Time
IT Outsourcing & Consulting
$70k-86k (estimate)
05/18/2024
07/20/2024
tsrconsulting.com
FARMINGTON, CT
200 - 500
1969
Public
DAVE CHALFON
$50M - $200M
IT Outsourcing & Consulting
Related Companies
About TSR Consulting Services, Inc
TSR is an employment agency that offers IT staffing and augmentation services for retail, healthcare and manufacturing sectors.
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