- Maintains quality presence on the shop floor; handles in-process materials and finished products; investigates and resolves any errors; conducts batch record reviews. Ensures that manufactured products meet all regulatory standards. Also, may participate in preparations for regulatory and customer audits.
- Reviews and approves general and/or complex manufacturing formulation batch production records to support product release as per specifications and SOPs.
- Inspects and approves intermediates or packaged drug products according to specifications.
- Monitors different processing stages and associated paperwork to ensure compliance with specifications.
- Drafts and reviews specifications and SOPs as necessary.
- Tracks and analyzes batch record errors, providing Quality Assurance management with valuable quality indicator data.
- Offers guidance to less experienced team members as needed.
- Conducts regular walkthroughs of GMP areas to provide sitewide support.
- Preferably holds a B.S. in Biology, Chemistry, or a related field, or equivalent.
- Minimum of 2 years of relevant experience in a regulated environment, with at least 2 years focused on product quality.
- Understanding of biotech product manufacturing processes.
- Familiarity with US and EU cGMP regulations and guidance.
- Experience with Oracle, BMRAM, MES, Veeva Infinity is a bonus.
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Quality Assurance Associate
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IQVIA Holdings, Inc. Seattle, United StatesProvide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspect Quality Assurance, Director, ...
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Quality Assurance Associate I
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Unavailable Seattle, United StatesOverview · Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center i ...
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IQVIA Seattle, WA, United StatesJob Overview:Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or Q ...
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Quality Assurance Associate II
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Unavailable Seattle, United StatesOverview · Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center ...
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Swing Shift Quality Assurance Associate
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Himalayan Dog Chew, LLC Arlington, United StatesJob Description · Job DescriptionNow Hiring Himalayan Pet Supply is looking for a Quality Assurance Associate to join our Swing Shift pack. · Himalayan Pet Supply began in 2003 with two brothers, a friend and his dog, Kaos. Kaos discovered 'churpi' and he loved it · We spent the ...
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Kaiser Bellevue, United States· Monday - Friday ~ regular day off Tuesday or thursday · flexible work situation - mix of clinic onsite and remote post-training · Job Summary: · Provide nursing care to a defined group of patients, adhering to Kaiser Foundation Health Plan of Washington ambulatory Nursing Car ...
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Kaiser Bellevue, United States· Position supports various specialties in Bellevue · 2-week onboarding commitment and subsequent training required · Monday - Friday Variable · Job Summary: · Provide nursing care to a defined group of patients on an on-call basis, adhering to Kaiser Foundation Health Plan of W ...
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Kaiser Seattle, United States Full time· 4 - 10s, hours and shifts vary based on department need · Job Summary: · Provide nursing care to a defined group of patients, adhering to Kaiser Foundation Health Plan of Washington ambulatory Nursing Care Standards, the Nursing Code of Ethics and Kaiser Foundation Health Plan ...
Quality Assurance Associate - Bothell, United States - SSi People
Description
Quality Assurance Associate
Join our Team as a Quality Assurance Associate
Work Schedule: Wednesday - Saturday, 6AM - 4:30PM EST
Job Overview:
Requirements: