Easter Seals Jobs

Job Title: QA Patients Operations Specialist

Location: Summit, NJ (Hybrid)

Hours/Schedule: M-F (normal business hours)

Type: Contract

Overview

Leading pharmaceutical company looking for an experienced QA Specialist. Ideal candidates should have a High School Diploma and at least 4 years of experience in the pharmaceutical industry or equivalent .

Responsibilities

• Provide Global Patient Services (GPS) system general support, data configuration approvals.

• Create and Maintain new Apheresis Accounts in company electronic supplier system (Veeva-SQM).

• Create and Maintain documentation in company 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

  Requirements

  Specific Knowledge, Skills, Abilities:

• Meticulous, precise, 3+ years with MS Office, fast learner, good communication skills

• Ability to think clearly and act in a decisive manner; communicate difficult observations in a calm and cogent manner.

• Interpersonal skills: good communicator, establishes a collaborative environment.

• Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.

• Adaptable/flexible and able to deal with change.

• Enterprise mindset and external focus.

  Education/Experience/ Licenses/Certifications:

• Minimum High School Diploma required

• Minimum of 4 years’ experience in pharmaceutical industry or equivalent.

• Good organizational skills, including ability to follow assignments through to completion.

• Innovative, proactive, and resourceful; committed to quality and continuous improvement.

• Independent decision-making capability and ability to think conceptually and understand impact of decisions, and to work with minimal supervision.

• Excellent verbal and written communication skill (English)

  Benefits

  System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.