QA Specialist - TechDigital Corporation
Summit, NJ
About the Job
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, CTDO
• Specific 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
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, CTDO
• Specific 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
Source : TechDigital Corporation