Quality - QA Associate QA Associate

2 weeks ago

Bothell, United States On-Board Companies Full time
On-Board Scientific is hiring a QA Associate in Bothell, WA
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position, Title, and State you are Located

About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:
Job title: Scientific QA Associate
Position Type: Full Time / 6-month contract
Job location: Bothell, WA 100% onsite
Shift: Sunday-Monday, 9PM-7:30AM

Responsibilities:
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.

Qualifications:
- 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.*
• 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

pply Today
www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.

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