What you will do

Let’s do this. Let’s change the world. In this vital role you will e responsible for overseeing the quality assurance of our document management processes, ensuring compliance with regulatory requirements and industry standard processes

Management of Controlled Documents

• Snr Associate shall check the documents in the Draft to Effective with Document Change Assessment (DCA) lifecycle for correctness and completeness per instructions and requirements provided in coordinator SOP and reject or approve per the SOP instructions. Each rejection reason must be entered in the tracking and QC form.

• Snr Associate will perform formatting of document per coordinator SOP requirements.

• Snr Associate will receive and complete request forms. Requests include but are not limited to: updating a document’s metadata, changing a document’s status, updating a document’s Targeted Effective Date.

Management of Document Obsoletions

• Snr Associate will initiate the document obsoletion process as requested per coordinator SOP.

Management of Periodic Review of Controlled Documents (Communication / Critical issue)

• Snr Associate will generate the Periodic Review report from the system and inform the required document owners/managers that have overdue periodic review controlled document(s).

• Snr Associate will manage, monitor and report on the periodic review process.

Management of Initial Regulatory Management

• Snr Associate to initiate the regulatory assessment step of document revision.

• Snr Associate completes regulatory assessment in CDOCS and determines no change is occurring or an assessment by a regulatory assessor is required.

• Snr Associate will route/assign documents to a regulatory assessor for completion of task.

Retention policies

• Follow retention policies outlined in Company Record Retention Schedule.

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

• Snr Associate will provide Performance Monitoring reports as required for Customer, Productivity and critical process controls to monitor Quality and Compliance

• Snr Associate will assist users in tracking and managing status of document revisions.

• Snr Associate will run monitoring reports as required.

Support Data Compilation for Deviation Trending Process

• Snr Associate will provide Performance data pull following company’s instructions to support the preparation of deviation trend reports in a quarterly frequency

• Performs approvals and rejections of Review/Approval workflows via company’s document management system according to SOPs, Guidelines.

• Maintains full understanding of documentation properties in order to perform proper execution of controlled documentation activities.

• Tracks and follows up on document discrepancies.

• Communicates document, system and hardware issues to the support team.

• Escalates unresolved issues appropriately to Management and DMS Support Team.

• Performs quality checks according to company’s procedures (SOPs).

• Other duties as assigned.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Master’s degree and 1 to 3 years of experience OR

• Bachelor’s degree and 3 to 5 years of experience OR Diploma and 7 to 9 years of experience

Preferred Qualifications:

• Knowledge of good documentation practices.

• Must be able to effectively communicate to document submitters to resolve any document discrepancies.

• Proficiency in the document classification taxonomy.

• Microsoft (MS) word, MS Excel, SharePoint proficiency, Documentum platform, Microsoft Outlook email.

• Ability to perform work that requires attention to detail and prioritization, and ability to multitask.

• High degree of verbal and written comprehension for the English language.

• Ability to work well with others and under time constraints, including ability to prioritize workload.

• Must grasp concepts quickly, react to change rapidly

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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