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    Qa Specialist

    Aequor
    3-4 years
    Not Disclosed
    Summit
    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.

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