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MANAGER
Metro Services, LLCIndianapolis, IN, US
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QA Operations Specialist
NovartisIndianapolis, IN, US
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ACL DigitalIndianapolis, IN, US
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QA Auditor 1
IQVIAIndianapolis, IN, US
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Manager
sns0025Indianapolis, IN, US
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International Medical GroupIndianapolis, IN, US
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ActalentIndianapolis, IN, US
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International MedicalIndianapolis, IN
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QA Auditor 1
IQVIA HoldingsIndianapolis, IN, US
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VirtualVocationsIndianapolis, Indiana, United States
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Manager, QA and RCM Training
RethinkFirstIndianapolis, IN, US
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Technican - QA
Eli Lilly and CompanyIndianapolis, Indiana, United States
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Professional Management EnterprisesIndianapolis, IN, US
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QA Operations Specialist
Novartis Group CompaniesIndianapolis, IN, United States
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Eli LillyIndianapolis, IN, US
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Clinical Documentation Integrity Specialist - QA
AledadeIndianapolis, IN, US
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QA Compliance Specialist
Katalyst HealthCares & Life SciencesIndianapolis, IN
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Minimum + years in a GMP-regulated biopharmaceutical environment.At least + years specifically in a QA role.Strong knowledge of QA Compliance systems including.
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Coordinator, QA
PLZ Aeroscience CorporationIndianapolis, IN, US
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PLZ is committed to product stewardship and innovation, strong ethical standards, sustainable operations and most importantly, the development of our people.
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To Lead QA related activities in assigned service sites to ensure compliance with State, Federal and company requirements. To ensure quality services are provided for each person served on a consistent basis in each program.
Responsibilities
Reviews BDS drafts daily
Completes BDS reports
Completes / submits Waiver Critical Incidents
Monitors & reviews investigations for timeliness / accuracy
Completes investigations
Site Visits Waiver & SGL
Participates with Record Reviews
Participates with Annual Waiver Reviews
Participates in PSRs
On call rotation on weekend for BDS reports
Participates in peer reviews.
Assists QAM with monthly roll ups / POC for record reviews, annual waiver review & PSRs
Ensures all QAC responsibilities are being carried out per policy and regulations
Qualifications
At least one year of supervisory experience in addition to thorough knowledge of human service program regulatory requirements for assigned area(s)
Bachelor’s degree in human services field preferred
Excellent writing and verbal communication skills are essential
Knowledge and experience in quality assurance systems is essential
Travel 25-75%
Must be willing to travel to service locations after hours and on weekends as needed