Job Title: QA Associate

Location: Bothell, WA

Hours/Schedule: Wednesday - Saturday, 6AM - 4:30PM

Compensation: $28.00 - $34.22/hr

Type: Contract, Potential for extension or conversion to permanent

Responsibilities

• 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.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.