Change Control Administrator

A

Anovorx Group LLC

Posted 3 months ago

Full Time

Memphis, Tennessee

In Person

Smart Summary

Responsibilities

The administrator provides administrative support for the change control process within the Quality Management System to ensure regulatory compliance. Key duties include logging change requests, monitoring timelines, and maintaining audit-ready records.

Qualifications

You have a Bachelor's Degree in Business Administration, Science, Communications, or a related field. You possess strong attention to detail, excellent communication skills, and proficiency in Microsoft Office Suite for reporting and data analysis.

Must Have Skills for ATS

QMS

Microsoft Office

Excel

Job Description

Job Summary:

The Change Control Administrator provides administrative support for the change control process within the Quality Management System (QMS). In this role, the Administrator ensures that all changes are properly logged, documented, and tracked to meet internal procedures and regulatory expectations. Working closely with the Change Control Manager and cross-functional teams, this position helps maintain audit-ready records, and monitors timelines.   The below is intended to describe the general content of and requirements for the performance of this job and is not to be construed as an exhaustive statement of essential functions, responsibilities, or requirements.

Primary Duties and Responsibilities

  1. Log, track, and monitor change requests in the Quality Management System (QMS), ensuring accuracy and compliance with established procedures.
  2. Review requests for completeness and clarity prior to routing for appropriate review and approval, minimizing delays in the change process.
  3. Maintain organized and audit ready records for all change controls, supporting compliance with applicable requirements.
  4. Monitor timelines, overdue items, and other performance metrics; prepare summary reports to highlight trends
  5. Support audit and inspection activities by coordinating, retrieving and presenting change control documentation as needed
  6. Collaborate with cross functional teams to answer questions, provide guidance on submission requirements, and ensure consistent application of the change control process.
  7. Regular and reliable attendance expected
  8. Other work-related duties as assigned by supervisor/manager

Minimum Knowledge, Abilities, and Skills Required

  1. A Bachelor's Degree in Business Administration, Science, Communications or related field.  
  2. Strong attention to detail, organizational skills and ability to manage multiple priorities.
  3. Excellent communication skills, both written and verbal.
  4. Strong analytical and problem-solving skills.
  5. Knowledge of office administrative procedures.
  6. Proficient in relevant software applications such as Microsoft Office (Word, Excel, PowerPoint) or similar tools for reporting and data analysis. 

A

Anovorx Group LLC

Dedicated. Exclusive. Unique. Anovo’s unique business is purpose-built exclusively for niche products designed to treat or impact rare diseases. As an all-in-one, exclusive partner, we are driven to deliver meaningful results for our partners and positive experiences for their patients. Coordinated by one management team, our integrated service model delivers customized program management, 3PL, specialty pharmacy, and patient care services. At Anovo, we’re solutions-oriented and focused on making a positive impact on behalf of our partners. Our team is uniquely suited to create a custom approach for each phase of the product lifecycle - from point of manufacture to patient experience. Find seamless management, meticulous quality checks, and appropriate solutions for every particular set of challenges through a single point of accountability and reassurance. We deliver to you exactly what we promise. To learn more about Anovo, visit http://www.anovorx.com today.
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