QA Associate - TAL
Bothell, WA, United States
"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title: QA Associate
Location: Bothell, WA 98021 (Remote)
Duration: 12 months
Pay rate: $28- 34.85/hr. on w2
Job Description:
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
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.