What are the responsibilities and job description for the QA Associate position at System One?
Title: QA Associate
Location: Bothell, WA
Start Date: ASAP
Schedule: Sunday - Wednesday, 9PM - 7:30AM PST
Pay Range: $25 - 34.90/hr
Type: Contract, Potential for extension or conversion to permanent
Responsibilities
Maintains 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.
• 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.
Requirements
• 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
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: Bothell, WA
Start Date: ASAP
Schedule: Sunday - Wednesday, 9PM - 7:30AM PST
Pay Range: $25 - 34.90/hr
Type: Contract, Potential for extension or conversion to permanent
Responsibilities
Maintains 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.
• 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.
Requirements
• 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
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Salary : $25 - $35
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