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Qa Specialist

3-4 years
Not Disclosed
10 July 10, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Information:

  • Employer: Aequor
  • Category: QA
  • Location:
    • Country: United States
    • State: New Jersey (NJ)
    • City: Summit
  • Post Date: 07/03/2024
  • Duration: 5 months or Until 30-Dec-2024 (May or may not extend depending on budget)
  • Work Schedule: M-F (normal business hours)
  • Onsite Requirement: 50% onsite

Job Description:

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. Responsibilities include:

  1. Global Patient Services (GPS) System Support:

    • Provide general support and 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.
  2. Interaction and Communication:

    • Interact with American and European technical departments both orally and in writing (English language required).
  3. Quality Operations and Systems Support:

    • Manage deviations, changes, CAPA, and provide compliance guidance.
    • Contribute to Key Performance Indicating metrics for continuous improvement.
  4. General Responsibilities:

    • This job description is intended to be general and should not be considered as all-inclusive.

Reporting Line:

  • Direct reporting to the Associate Director of the Global Quality Patient Operations and Apheresis Regulatory Vigilance, CTDO.

Specific Knowledge, Skills, Abilities:

  • Skills:

    • Meticulous, precise, and able to work independently.
    • Good communication skills, with the ability to think clearly and act decisively.
    • Establishes a collaborative environment and communicates difficult observations calmly.
  • Experience:

    • 3+ years of experience with MS Office.
    • Minimum of 4 years' experience in the pharmaceutical industry or equivalent.
    • Demonstrated ability to work in a complex and changing environment.
  • Attributes:

    • Adaptable and flexible.
    • Enterprise mindset with an external focus.
    • Good organizational skills and the ability to follow assignments through to completion.
    • Innovative, proactive, and resourceful.
    • Committed to quality and continuous improvement.
    • Independent decision-making capability and conceptual thinking.
    • Excellent verbal and written communication skills (English).

Education/Experience/Licenses/Certifications:

  • Education:

    • Minimum High School Diploma required.
  • Experience:

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

Travel:

  • This position does not require travel.

Additional Information:

We offer a collaborative and supportive working environment, emphasizing personal and professional growth. Our core values include quality, integrity & trust, drive & passion, agility & responsiveness, belonging, and collaborative partnerships. Join us to be part of an exciting journey to make a positive impact in patients' lives.