Qa Specialist

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:

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.
Interaction and Communication:
- Interact with American and European technical departments both orally and in writing (English language required).
Quality Operations and Systems Support:
- Manage deviations, changes, CAPA, and provide compliance guidance.
- Contribute to Key Performance Indicating metrics for continuous improvement.
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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