Careers

JOB SUMMARY  

Supports the execution of the quality management program across all functional areas within a quality management framework governed by FDA, other regulations and a complex ecosystem of internal and external stakeholders.   

Essential Functions 

• Execute activities related to planning, development, implementation, and evaluation of quality management strategies and initiatives targeting our varied corporate, clinical and client audiences. 

• Routinely support the ongoing maintenance of SOPs, Policies and Procedures, Work Instructions, Form/Templates, and training initiatives in accordance with governing industry standards, guidelines, Federal regulations, and company quality framework.  

• Support the identification and implementation of new technologies and methodologies for quality management.  

• Maintain an electronic quality management system compliant with our regulatory framework.  

• Ensure that controlled documents and training records are audit ready.  

• Performs internal audits of records including training records, and clinical research documentation using standard quality auditing methodologies.  

• Monitor quality tracking systems to identify systemic quality issues, areas of quality improvement, and issues requiring a CAPA.  

• Support company audits and qualification assessments from customers and Federal Agencies.   

• Work with Subject Matter Experts to conduct risks assessments of quality events, root-cause analysis, corrective and preventative measures, and effectiveness checks.  

• Identify quality issues and work with the stakeholders to resolve issues.   

• Foster a culture of continuous learning and compliance.  

• Support computer system validation documentation and business continuity documentation needs.  

• Track key quality indicators. 

• Establish high levels of quality, accuracy, and process consistency.  

QUALIFICATION AND EDUCATION REQUIREMENTS  

• Bachelor’s Degree, or certification in clinical research  

• Experience with electronic quality management systems, salesforce experience is preferred 

• Direct audit experience, ISO9000 preferred 

• Validation experience preferred  

• Strong Office 365 experience   

• Strong interpersonal and communication skills  

• Strong analytical and organizational skills  

• Self-motivated and self-directed  

• Ability to work closely with a management team  

WORKING CONDITIONS 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers. 

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand. 

Minimal (less than 10%) travel is required for this position. 

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position.  They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel.  More in-depth information can be found in SOP's, working guidelines, policies, etc. 

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.