Position Details:

Job Title: QA Associate

Location: 22026 20th Ave. SE, Bothell, WA, 98021

Duration: 12 Months Contract

Job Description:

Job Title: QA Associate

Location: Bothell, WA*100% onsite

Work Schedule: Sunday-Wednesday, 9PM - 7:30AM PST*

Top Skills -

- Documentation Review experience

- Scientific Degree

- Experience working in a GMP environment

*Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.*

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

Additional Job Requirements:

• Lab w/ blood & animal

Job Type: Contract

Pay: $30.00 - $35.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Night shift

Work setting:

• In-person

Education:

• Bachelor's (Preferred)

Experience:

• Documentation Review: 1 year (Preferred)
• GMP: 1 year (Preferred)

Ability to Commute:

• Bothell, WA 98021 (Preferred)

Work Location: In person