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QA Contractor, GMP Quality Assurance
$30 - $40 / hour
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Overview
Job Description
- Manage assigned day-to-day QA responsibilities in support of the company's Product Quality systems.
- Provide timely support for Third Party Deviations, Third Party Change Controls, and Vendor Management (qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers) activities.
- Liaison with applicable department record owners to ensure their complete and timely resolution.
- Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues, as needed.
- Communicate project status to stakeholders and escalate issues in a timely manner.
- Perform daily customer-facing activities, as assigned by area management.
- Perform and support other duties as assigned by area management.
- Bachelor's degree in a scientific field and 2+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 5+ years of GMP based Quality Assurance experience using a company QMS.
- Experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement.
- Strong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
- Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
- Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
- Strong service-oriented mindset with excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.).
akarsh.yathiraj@leadstackinc.com
| Thanks and RegardsAkarsh Yathiraj |
| Senior Recruiter |
| C. | (415) 322-5419 |
| D. | (415) 322-5419 |
| A. | 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 |
| W. | www.leadstackinc.com |
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