QA Associate - Eclaro
Bothell, WA
About the Job
QA Associate
Job Number: 24-01795
Job Number: 24-01795
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate for our client in Bothell, WA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- 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.
Qualifications:
- Documentation Review experience
- Experience working in a GMP environment
- Scientific Degree; has biology or similar degree who are looking for GMP experience.
- 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
Pay Rate: $35.70/hr.
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
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
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.
Source : Eclaro