QA Specialist
omni inclusiveSummit (NJ)
About the role
50% onsite
Work Schedule: M-F(normal business hours)
The primary responsibility of the Global QA Patients Operations Specialist is to support the Onboarding and Maintenance of Apheresis Centers in Client systems and tools. Provide Global Patient Services (GPS) system general support, data configuration approvals. Create and Maintain new Apheresis Accounts in Client electronic supplier system (Veeva-SQM).Create and Maintain documentation in Client electronic documentation system (Veeva-BMSDocs).Complete daily entry of data in the Onboarding Tracker tool. Interact with American and European technical departments both orally and in writing (English language required).Quality Operations and Systems Support including deviation management, change management, CAPA, compliance guidance. Contribute to the Key Performance Indicating metrics to ensure continuous improvement. This is intended to be a general job description and should not be considered as all-inclusive. Direct reporting line to the Associate Director of the Global Quality Patient Operations and Apheresis Regulatory Vigilance, CTDOSpecific Knowledge, Skills, Abilities: Meticulous, precise, 3+ years with MS Office, fast learner, good communication skills o Ability to think clearly and act in a decisive manner; communicate difficult observations in a calm and cogent manner. o Interpersonal skills: good communicator, establishes a collaborative environment. o Demonstrated ability to work independently or with groups of people/teams in a complex changing environment. o Adaptable/flexible and able to deal with change. o Enterprise mindset and external focus.
Education/Experience/ Licenses/Certifications:
Minimum High School Diploma required o Minimum of 4 years' experience in pharmaceutical industry or equivalent. o Good organizational skills, including ability to follow assignments through to completion. o Innovative, proactive, and resourceful; committed to quality and continuous improvement. o Independent decision-making capability and ability to think conceptually and understand impact of decisions, and to work with minimal supervision. o Excellent verbal and written communication skill (English)
Travel: This position does not require travel
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