QA Associate (biology, Documentation Review experience & GMP)

JOB TITLE: QA Associate

Location: Bothell, WA (100% onsite)

Duration: 6 months initial (potential extension/potential right to hire)

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.

1. 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.

2. Inspects and releases intermediates or packaged drug product per specifications.

3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.

4. Drafts and reviews specifications and SOPs.

5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.

6. May provide guidance to less experienced staff.

7. 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

If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to June@eclaro.com or call (212)804-7476.

If hired, you will enjoy the following Eclaro Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.