|
SUMMARY OF POSITION: This Learning Management Administrator also known as Quality Associate, Records Management is responsible for supporting quality assurance resources and establishing team goals and objectives in alignment with corporate quality goals. Establishing and maintaining quality standards and measures across WCG services organizations and ensuring such standards comply with regulatory requirements and best practices as they relate to Learning Management Systems (LMS). This position is responsible for working alongside WCG leadership to achieve corporate and departmental compliance goals as well as ensuring the CTS organization remains compliant with the Quality Management System and business processes.
VACCINATION REQUIREMENT:
To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date. EDUCATION REQUIREMENTS:
- Bachelor's degree or local equivalent in medicine, science, technology, or equivalent degree/experience.
CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:
- Certifications for quality professionals through the Society for Quality Assurance, American Society for Quality or comparable certifications are desirable.
QUALIFICATIONS/EXPERIENCE:
- Two to four (2-4) years' experiences in a quality/regulatory compliance position with evidence of increasing responsibility.
- Knowledge of current regulatory and GCP guidelines as they apply to clinical trials.
- Familiarity and experience with audit preparation as well as assisting/facilitating customer and/or process audits.
- Significant technical writing skills.
- Experience in training others on standards and ensuring compliance with employee education/LMS.
- Effective communication (written and oral) skills, organization and interpersonal skills as well as the ability to interact with WCG staff and clients as needed.
- Knowledge and understanding of drug development and the clinical trial process.
- Ability to problem solve and engage in the resolution of conflicts.
- Ability to work efficiently and independently.
- Proficiency with a learning management system (LMS) as well as MS Word, MS Excel, and MS PowerPoint.
ESSENTIAL DUTIES/RESPONSIBILITIES:
- Support the continued development, maintenance, and enforcement of the CTS Quality Management System.
- Support the administration, documentation, and reporting of LMS training.
- Provide LMS support during audits and inspections.
- Provide quality standards as it relates to records management.
- Engage in a professional and efficient collaboration with WCG personnel who author training documents and/or courses for implementation into the LMS.
- Support the implementation of adding, revising, and/or retiring training documents and courses in the LMS.
- Assist in the development of training curricula based on job titles and roles in collaboration with department heads.
- Ensure appropriate training is delivered to WCG personnel in a timely manner.
- Support the implementation and delivery of WCG required training to WCG personnel, including personnel associated with WCG business acquisitions.
- Assist the subject matter expert with respect to the integration procedure for LMS document management processes.
- Support the transition of the LMS system for WCG acquisition companies into the WCG framework, as applicable.
- Support the implementation and delivery of WCG controlled documents to ensure same is performed in line with industry standards, and regulatory agency regulations and guidance, including but not limited to, GCP.
- Assist in the investigation of LMS system issues and process improvements.
- Support troubleshooting issues & all request types that are reported by personnel to the Records management department.
- Provide input and assist in the resolution of issues related to course design and configuration.
- Communicate and document system issues related to infrastructure for resolution by LMS vendor.
- Assist with proposals for upgrades to the system to foster process improvements and customer satisfaction.
- Maintain current knowledge with respect to the quality of documents and regulatory compliance best practice.
- Conduct internal audits/periodic review of WCG processes and procedures related to the LMS.
- Identify compliance gaps and provide support and suggestions for remediation to the Director, Quality Assurance & Compliance.
- Train LMS personnel to ensure system processes and procedures are maintained.
- Provide training and guidance to staff regarding compliance and interpretation of regulations.
- Notify personnel of updated document versions and how to access them.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
- Attendance and punctuality are essential functions of the position.
TRAVEL REQUIREMENTS: Must be able to travel up to 20% on a as needed basis.
#HP
#LI-REMOTE
#LI-SA1
|
WIRB - Copernicus Group
October 28, 2022