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Senior Associate Quality Assurance

1-3 years
Not Disclosed
10 Nov. 26, 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, CPC Certified, 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

What You Will Do
Let’s make an impact together. In this crucial role, you will be responsible for overseeing the quality assurance of our document management processes, ensuring compliance with regulatory requirements and industry standards.

Management of Controlled Documents

As a Senior Associate, you will review documents in the Draft to Effective with Document Change Assessment (DCA) lifecycle to ensure they meet correctness and completeness per the coordinator SOP. You will either approve or reject documents following SOP instructions, with each rejection documented in the tracking and QC form.

You will also perform formatting of documents as per the coordinator SOP and handle document requests, including updates to metadata, changes to document status, and updates to the targeted effective date.

Management of Document Obsoletions

You will initiate the document obsoletion process as needed per the coordinator SOP.

Management of Periodic Review of Controlled Documents

You will generate periodic review reports from the system and notify document owners/managers of overdue reviews. You will manage, monitor, and report on the periodic review process.

Management of Initial Regulatory Management

You will initiate the regulatory assessment step for document revisions, determining whether a regulatory assessment is needed. If required, you will route documents to a regulatory assessor.

Retention Policies

You will follow retention policies outlined in the Company Record Retention Schedule.

Support and Performance Monitoring for Users/Customer Responsiveness, Compliance, Quality, and Productivity

You will provide performance monitoring reports on customer service, productivity, and critical process controls to ensure quality and compliance. Additionally, you will assist users in tracking and managing document revision statuses.

Support Data Compilation for Deviation Trending Process

You will compile performance data to support the preparation of deviation trend reports on a quarterly basis.

Approval and Rejection of Review/Approval Workflows

You will perform approvals and rejections of review/approval workflows via the company’s document management system in accordance with SOPs and guidelines.

Quality Checks and Issue Resolution

You will perform quality checks according to company procedures (SOPs) and track document discrepancies. Additionally, you will communicate document, system, and hardware issues to the support team, escalating unresolved issues to management and the DMS Support Team.

Other Duties

You will be expected to perform other related duties as assigned.


What We Expect of You
We are looking for a detail-oriented professional with the following qualifications:

Basic Qualifications:

  • Master’s degree with 1 to 3 years of experience, OR
  • Bachelor’s degree with 3 to 5 years of experience, OR
  • Diploma with 7 to 9 years of experience

Preferred Qualifications:

  • Knowledge of good documentation practices
  • Proficiency in Microsoft Word, Excel, SharePoint, Documentum platform, and Microsoft Outlook
  • Ability to perform detailed work, prioritize tasks, and multitask
  • Strong verbal and written comprehension of the English language
  • Ability to collaborate well with others and manage time effectively under pressure

What You Can Expect of Us
At Amgen, we are committed to both your professional and personal growth. We offer a comprehensive benefits package, including competitive pay and a Total Rewards Plan that aligns with industry standards. Our collaborative culture will support you every step of the way.


Apply Now
For a career that challenges and inspires, join us.

Keyword: Senior Associate, Document Management

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