Job Title: QA Specialist
Job Location: Summit, NJ
Job Duration: 5 months
Job Description: 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.
- 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 skillso 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 requiredo 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
Additional Job Requirements:None
Job Type: Contract
Pay: $35.00 - $37.00 per hour
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to Commute:
Work Location: In person