Document Control Specialist I

2 weeks ago

Hamilton, Canada Fusion Pharmaceuticals US Inc Full time

**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.

  • Document Control Specialist

    4 days ago

    Hamilton, Canada Heddle Marine Service Inc Full time

    **Position Summary**: The Document Control Specialist plays a crucial role in managing all project’s related documentation, ensuring documents are recorded/filed, as well as up to date, and that proper procedures for documentation are developed and are within compliance. **Responsibilities**: - Establish and maintain a comprehensive document control...

  • Document Controller

    1 month ago

    Hamilton, Canada MiCiM Ltd Full time

    MiCiM provide focused, end to end project management and construction delivery services, specialising in the Data Centre and Mission Critical sectors. We work with our clients to develop their best-in-class facilities in an open, honest and collaborative manner.We are looking for an experienced Document Controller to join our growing team.You will manage the...

  • Document Controller

    1 month ago

    Hamilton, Canada MiCiM Ltd Full time

    MiCiM provide focused, end to end project management and construction delivery services, specialising in the Data Centre and Mission Critical sectors. We work with our clients to develop their best-in-class facilities in an open, honest and collaborative manner.We are looking for an experienced Document Controller to join our growing team.You will manage the...

  • Document Controller

    1 month ago

    Hamilton, Canada MiCiM Ltd Full time

    MiCiM provide focused, end to end project management and construction delivery services, specialising in the Data Centre and Mission Critical sectors. We work with our clients to develop their best-in-class facilities in an open, honest and collaborative manner.We are looking for an experienced Document Controller to join our growing team.You will manage the...

  • CNC & Machine Specialist

    2 weeks ago

    Hamilton, Canada I-Cubed Industry Innovators Inc. Full time

    Job Description All personnel at I-Cubed and Southport are required to work hard, enjoy their work and be skilled at what they do. The CNC & Machine Specialist is key member of the machine shop team and is responsible for producing machined parts by programming, setting up, and operating a computer numerical control (CNC) machine and/or conventional milling...

  • Protection & Control Specialist

    2 weeks ago

    Hamilton, Canada Spark Power Full time

    **Protection & Control Specialist Headquartered in Hamilton, Ontario, Protection & Control Engineering East Department has been providing testing and engineering services throughout Southern Ontario since 1970. **What will you do as a **Protection & Control Specialist **at Spark Power** - The primary role of a Protection & Control Specialist is to perform...

  • Microbiologist I, Quality Control

    2 weeks ago

    Hamilton, Canada OmniaBio Full time

    **Reports to**:Microbiology Supervisor,** **Quality Control **Position Summary**: As Microbiologist I, Quality Control, at OmniaBio, you are a motivated individual in the field of quality control (QC) microbiology for Good Manufacturing Practices (GMP) manufacturing. The QC team is responsible for all aspects of QC for the organization and the...

  • Associate I, Quality Control

    2 weeks ago

    Hamilton, Canada OmniaBio Full time

    **Position Summary**: As the Associate I, Quality Control at OmniaBio, you are a motivated individual with a keen interest in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The...

  • Robotics & Controls Specialist

    2 weeks ago

    Hamilton, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation. **Duties & Responsibilities** - Offline programming of robotic systems comprising of the following elements: - PLC (Siemens, Allen Bradley, & Beckhoff) - Robot (ABB) - HMI (Siemens & Allen Bradley) - Vision...

  • Control & Drive Systems Specialist

    3 weeks ago

    Hamilton, Canada ArcelorMittal Dofasco Full time

    Requisition ID: 29847 Do you want to work at one of **Canada’s Top 100 Employers?** We’re looking for people who are driven by excellence to work with innovative technology to create the material tomorrow’s world will be made of. At ArcelorMittal Dofasco, we play a key role in North America’s advanced manufacturing supply chain working with the...

  • Microbiologist I, Quality Control

    1 week ago

    Hamilton, Ontario, Canada OmniaBio Full time

    Reports to:Microbiology Supervisor, Quality ControlPosition Summary:As Microbiologist I, Quality Control, at OmniaBio, you are a motivated individual in the field of quality control (QC) microbiology for Good Manufacturing Practices (GMP) manufacturing. The QC team is responsible for all aspects of QC for the organization and the Microbiologist I, Quality...

  • Quality Control Specialist

    2 weeks ago

    Hamilton, Canada Lafarge Canada Full time

    Whatever you do, you'll make a difference at Lafarge Canada. Because we know that your passion and curiosity are the natural resources the world needs. Thanks to our teams' energy, commitment and ideas, we are reinventing how the world builds to make Canada greener and smarter for all. Quality Control Specialist **Requisition...

  • Robotics & Controls Specialist

    1 week ago

    Hamilton, Ontario, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation.Duties & Responsibilities Offline programming of robotic systems comprising of the following elements:PLC (Siemens, Allen Bradley, & Beckhoff) Robot (ABB) HMI (Siemens & Allen Bradley) Vision (IFM & Keyence)...

  • Associate I, Quality Control

    1 week ago

    Hamilton, Ontario, Canada OmniaBio Full time

    Position Summary:As the Associate I, Quality Control at OmniaBio, you are a motivated individual with a keen interest in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The Associate I,...

  • Robotics & Controls Specialist

    1 week ago

    Hamilton, Ontario, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation. Duties & ResponsibilitiesOffline programming of robotic systems comprising of the following elements: PLC (Siemens, Allen Bradley, & Beckhoff) Robot (ABB) HMI (Siemens & Allen Bradley) Vision (IFM &...

  • Robotics & Controls Specialist

    2 weeks ago

    Hamilton, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation. Duties & Responsibilities Offline programming of robotic systems comprising of the following elements: PLC (Siemens, Allen Bradley, & Beckhoff) Robot (ABB) HMI (Siemens & Allen Bradley) Vision (IFM &...

  • Robotics & Controls Specialist

    2 weeks ago

    Hamilton, Canada Radian Robotics Full time

    Reporting to the Controls Manager, the Controls Specialist will support projects and field services activities including programming and documentation. Duties & Responsibilities Offline programming of robotic systems comprising of the following elements: PLC (Siemens, Allen Bradley, & Beckhoff) Robot (ABB) HMI (Siemens & Allen Bradley) Vision (IFM &...

  • Microbiologist I, Quality Control

    1 week ago

    Hamilton, Ontario, Canada OmniaBio Full time

    Reports to: Microbiology Supervisor, Quality ControlAbout OmniaBio:OmniaBio Inc. is a subsidiary of Toronto-based CCRM ), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio's facility will be Canada's first commercial scale contract development and manufacturing organization (CDMO)...

  • Associate I, Quality Control

    1 week ago

    Hamilton, Canada OmniaBio Full time

    About OmniaBio:OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is...

  • Associate I, Quality Control

    1 week ago

    Hamilton, Canada OmniaBio Full time

    About OmniaBio:OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is...