Document Control Specialist I

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.

Position Summary

Fusion has opened a newly created role in Quality Assurance for a Document Control Specialist I. The Document Control Specialist I will be responsible for processing and managing documents from initiation to release in the Veeva QualityDocs eDMS. This person will also be responsible for issuing batch records, worksheets, logbooks, and other requested documents to support an array of departments such as QC, Manufacturing, and Quality Assurance. This role will report to the Director or Associate Director of Site Quality.

Key Responsibilities

• Facilitate the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement).
• Processing documents undergoing Document Change Control (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices
• Issuance of batch records, logbooks, worksheets, and other requested GxP documents to support QC, clinical, and commercial manufacturing.
• Maintenance of Procedural Document Binders or electronic equivalent.
• Electronically scan and physically file executed documents / records such as batch records, protocols, and etc. to their designated location.
• Maintain Document Control file rooms to ensure they are organized, structured, and locations identified to ensure documents / records are preserved, retrievable and accessible in a timely manner.

• Responsible for ensuring that GMP records are maintained, secure, and retrievable throughout defined retention periods. This may include document archival and or retrieval at off-site storage per cGMP regulations.

• Support the document periodic review process.
• Ensure daily activities adhere to the documented quality system and current regulatory requirements.
• May participate in cross-functional project teams as a department representative.
• May provide support with regulatory audits and inspections as required.
• Perform other duties and responsibilities as assigned.

Required Qualifications

• Bachelor’s degree or equivalent experience
• 2+ years of experience in FDA regulated environment e.g. pharmaceutical, biotech, or medical device and experience in using an electronic document management system (eDMS)
• Knowledge of understanding of Quality Systems and applicable GMP regulations and standards
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy
• Effective written and oral communication skills
• Effective time management and interpersonal skills
• Possesses initiative and is proactive
• Knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe
• Must work effectively within teams with rapidly changing priorities
• Builds productive internal and external working relationships

Fusion requires all employees to be current with their COVID vaccination requirements.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.