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MMS
Seattle, WA, United States
MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creati
Job Source: MMSPalantir Technologies
Seattle, WA, United States
A World-Changing Company Palantir builds the world’s leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our partners to develop lifesaving drugs, forecast supply chain disruptions, locate missing children, and more. The Role Palantir Technologies is seeking a Qualit
Job Source: Palantir TechnologiesLa Panzanella Artisanal Foods Co.
Tukwila, WA, United States
Dare Foods Limited , a leading Canadian manufacturer and distributor of quality biscuits, crackers, fine breads, confectionery products, and portable snacks, is seeking a highly motivated and energetic individual with a strong passion for food to join our Tukwila, Washington Manufacturing team. QA Compliance Specialist As a member of the Operation
Job Source: La Panzanella Artisanal Foods Co.Verathon, Inc.
Bothell, WA, United States
Verathon, Inc. Compliance Specialist II Bothell , Washington Apply Now Compliance Specialist IILocationUS-BothellID2024-1244CategoryQuality Assurance/Regulatory AffairsPosition TypeFull-TimeWork ModelHybridCompany OverviewVerathon is a global medical device company focused on supporting customers by being their trusted partner, delive
Job Source: Verathon, Inc.Bristol-Myers Squibb
Bothell, WA, United States
Manager, Quality Compliance page is loaded Manager, Quality Compliance Apply locations Bothell - WA - US time type Full time posted on Posted 2 Days Ago job requisition id R1580616 Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at B
Job Source: Bristol-Myers SquibbHiring Now!
Bothell, WA, United States
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transfo
Job Source: Hiring Now!Philips
Bothell
The Senior Good Clinical Practice (GCP) Auditor will play a critical role in ensuring Philips’ Clinical Studies and practices are compliant with Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good Clinical Practice (GCP) audits in line with defined methodology. + Planning, coordinating, and executing clinic
Job Source: PhilipsKennedy/Jenks Consultants
Seattle, WA, United States
Kennedy/Jenks Consultants Senior Air Quality Specialist Seattle , Washington Apply Now Senior Air Quality SpecialistCalifornia, USA * Oregon, USA * Washington, USAReq #212Tuesday, February 27, 2024Founded in 1919, KJ has always looked to the future. With a talented team of professionals and a culture of continuous improvement, we de
Job Source: Kennedy/Jenks ConsultantsSeattle, WA, United States
MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn .
Job Specific Skills:
Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
Understanding of how to plan, prepare andconduct GCP auditsindependently.
Proficient in authoring and managing audit documents independently.
Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc. independently.
Develop CAPA plans and contribute to resolution of audit findings independently.
Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently.
Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada.
Requirements: College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
Minimum of 5 years’ experience inGCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.)
Expert knowledge of scientific principles and concepts.
Reputation as emerging leader in field with sustained performance and accomplishment.
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred.
Good communication skills and willingness to work with others to clearly understand needs and solve problems.
Excellent problem-solving skills.
Good organizational and communication skills.
Proficient with 21 CFR Part 11, FDA, and GxP requirements.
Expertise within CROs and scientific and clinical data/ terminology, and the drug development process.
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Senior Quality and Compliance Specialist (GCP Auditor) jobs in Seattle, WA, United States
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