Quality Assurance Specialist - Bothell, United States - SSi People

Description

Role: Quality Assurance Specialist

Location: Bothell, WA (Onsite)

Contract: 6 Months

Top Skills:

• years of GMP work experience
• with Batch Records
• Experience Preferred
• or BA Degree preferred, or HS Diploma + relevant work experience
• skills include- strong cross-functional experience, strong interpersonal skills

ROLES AND RESPONSIBILITIES:

• executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.??
• Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.
• technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities.?
• deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs).?

Education:

• degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.??
• years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.??