About the Role
Quality Systems Associate
Cambridge, MA / Remote
The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
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 Nuvalents 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 SOPs 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:
- Bachelors 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.