The Role:

Reporting to the Associate Director, Quality Systems, the Quality Systems Associate will be responsible for assistance with the daily administration of the quality management system document/records management. This person will assist with providing technical and compliance support that will influence, educate, and positively impact Nuvalent data integrity and support Nuvalent’s quality culture.

Responsibilities:

• Assist with review of documents under revision, issuance of records, tracking of controlled documents, and management of the Quality Files.
• Provide assistance to users on the process of writing SOP’s and other documents.
• Assist with administering GxP implemented quality management systems, assign and track training.
• Track procedural document record archives for all GxP functions.
• Track and trend deviations, change controls, CAPA and product complaints to closure.
• Responsible for delivery of training programs, as well as, prepare and provide training reports.
• Provide training follow-up reminders and status updates for assigned training.
• Assist with providing system admin technical support for GxP implemented electronic systems.
• Assist with the management of Audit Program activities including document management, tracking, notifications, metrics, and reporting.
• Supports all training activities within the Quality team for the entire company.

Competencies:

• Cross-functional collaboration, excellent communication skills, flexibility with changing priorities, strong attention to detail, and the ability to work well under pressure and take on unfamiliar tasks.
• Ability to work productively primarily from home in a fast-paced, results-driven, highly accountable environment where you can demonstrate initiative and make a clear impact.
• Ability to think critically with strong attention to detail.
• Excellent organization and multi-tasking skills and ability to drive and deliver multiple projects within project scope and timelines.

Qualifications:

• Bachelor’s degree in biology, chemistry, or a life sciences field is preferred or related experience.
• 3 years of experience in the pharmaceutical industry.
• Experience in Document Control and Quality Events monitoring.
• Experience with Electronic Quality Systems.
• Experience with ELMS and Electronic Training Systems.