Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Maple Grove, MN
View more jobs in Minnesota

Job Details

We're Sorry..

The job you clicked on has expired or has been removed and is no longer available. The original listing can be found at the bottom of the page for your reference.

New Search

Pr Clinical QA Specialist (remote work-US only) Job

This job is expired..
Location
Maple Grove, MN
6 hit(s)  

Profile

\u003Cp\u003E\u003Cstrong\u003EPrimary Location:\u003C/strong\u003E [[filter2]]\u003Cbr\u003E\u003Cstrong\u003EAdditional Locations:\u003C/strong\u003E US-CA-San Jose; US-CA-Valencia; US-IN-Spencer; US-MA-Boston; US-MN-Arden Hills\u003Cbr\u003E\u003Cstrong\u003ERequisition ID:\u003C/strong\u003E 431395\u003C/p\u003E\u003Cp\u003E\u00a0\u003C/p\u003E\u003Cp\u003E\u00a0\u003C/p\u003E\u003Cp\u003E\u003Cspan style=\font-size: 14px;\\u003E\u003Cspan style=\font-family: arial, helvetica, sans-serif;\\u003E\u003Cstrong\u003E\u003Cem\u003E** This position can be field based anywhere in the U.S.\u003C/em\u003E\u003C/strong\u003E\u003C/span\u003E\u003C/span\u003E\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u003Cstrong\u003EAbout this role:\u003C/strong\u003E\u003C/p\u003E\u003Cp\u003EAssists the Manager, Clinical QA, with internal quality assurance program for the assigned business area.\u0026nbsp; Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u003Cstrong\u003EYour\u0026nbsp;Responsibilities: \u003C/strong\u003E\u003C/p\u003E\u003Cul\u003E\u003Cli\u003EParticipates on clinical project teams, influences clinical teams toward a state of inspection readiness at all times\u003C/li\u003E\u003Cli\u003EPlans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials.\u003C/li\u003E\u003Cli\u003EServes as lead auditor\u003C/li\u003E\u003Cli\u003ECommunicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.\u003C/li\u003E\u003Cli\u003EReview, revise, update and maintain Clinical AVL and manages updates to the clinical vendor audit database.\u003C/li\u003E\u003Cli\u003EAssesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures\u003C/li\u003E\u003Cli\u003EAssesses the accuracy, validity, and quality of the scientific data generated during clinical trials\u003C/li\u003E\u003Cli\u003EParticipates in problem-solving with project teams at investigator sites\u003C/li\u003E\u003Cli\u003ECommunicates observations to clinical investigators, clinical program managers, directors, and management\u003C/li\u003E\u003Cli\u003EDocuments audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed\u003C/li\u003E\u003Cli\u003EEnsures tracking of audit findings\u003C/li\u003E\u003Cli\u003EContributes to the development of audit procedures and processes\u003C/li\u003E\u003Cli\u003EAssists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.\u003C/li\u003E\u003Cli\u003ESupports the preparation, coordination, and management of regulatory agency sponsor inspections of BSC offices\u003C/li\u003E\u003Cli\u003EAssists in preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings\u003C/li\u003E\u003Cli\u003EKeeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.\u003C/li\u003E\u003Cli\u003ESupport to the Clinical organization in meeting BSC Quality system requirements\u003C/li\u003E\u003Cli\u003ESupports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners providing quality input\u003C/li\u003E\u003Cli\u003EMay support clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements.\u003C/li\u003E\u003Cli\u003ESupports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings.\u003C/li\u003E\u003Cli\u003EPlans, schedules, and conducts vendor audits\u003C/li\u003E\u003C/ul\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u003Cstrong\u003EWhat we are looking for:\u003C/strong\u003E\u003C/p\u003E\u003Cp\u003E\u003Cstrong\u003EBasic Qualifications:\u003C/strong\u003E\u003C/p\u003E\u003Cul\u003E\u003Cli\u003EBachelor\u0026rsquo;s degree in Life Sciences and 6 years of experience or Master\u0026rsquo;s degree and 4-7 years of experience\u003C/li\u003E\u003Cli\u003EMinimum 6 years\u0026rsquo; experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines; clinical QA and/or compliance experience; minimum 3 years direct clinical quality (GCP) auditing experience\u003C/li\u003E\u003Cli\u003ETravel up to 50% can be expected including international\u003C/li\u003E\u003C/ul\u003E\u003Cp\u003E\u003Cstrong\u003EPreferred Qualifications\u003C/strong\u003E\u003C/p\u003E\u003Cul\u003E\u003Cli\u003EMedical device experience desired\u003C/li\u003E\u003Cli\u003EGCP/auditing certification preferred\u003C/li\u003E\u003C/ul\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cul\u003E\u003C/ul\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cul\u003E\u003C/ul\u003E\u003Cp\u003E\u0026nbsp;\u003C/p\u003E\u003Cp\u003E\u00a0\u003C/p\u003E\u003Cp\u003EBoston Scientific is an Equal Opportunity Employer.\u003C/p\u003E\u003Cp\u003E\u00a0\u003C/p\u003E\u003Cp\u003E\u003Cspan style=\color:#a9a9a9\\u003E\u003Cspan style=\font-size:9.0px\\u003EPosting Notes: [[filter2]]||US-CA-San Jose; US-CA-Valencia; US-IN-Spencer; US-MA-Boston; US-MN-Arden Hills||Quality||[[mfield2]]\u003C/span\u003E\u003C/span\u003E\u003C/p\u003E,datePosted:2018-07-12,employmentType:FULL_TIME,industry:Engineering/Architect/Design,hiringOrganization:{@type:Organization,name:Boston Scientific},identifier:{@type:PropertyValue,name:Boston Scientific,value:431395-en_US},jobLocation:{@type:Place,address:{@type:PostalAddress,addressCountry:US,streetAddress:,addressLocality:Maple Grove,addressRegion:MN,postalCode:55311}}}

Company info

Boston Scientific Corporation
Website : http://www.bostonscientific.com

By using Employment Crossing, I was able to find a job that I was qualified for and a place that I wanted to work at.
Madison Currin - Greenville, NC
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
PRCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
PRCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2018 PRCrossing - All rights reserved. 21