Technical Writer

4 weeks ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

**AtomVie Global Radiopharma Inc. **is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

We are a community that challenges ourselves professionally, are proud of what we can accomplish together, and take pride in the impact that we can make with our clients and patients across the globe. We can’t wait for you to begin your career with AtomVie and to help us achieve our vision: to transform lives by revolutionizing healthcare.

**About the Role**

Reporting to the Manufacturing Process Manager, the **Technical Writer** will provide practical, technical, and operational support by authoring, editing and/or providing input on documents associated with successful manufacturing operations and will also provide support with continuous improvement projects. This role works cross-functionally with internal departments and external resources on technical writing related issues.

**What You Will Do**
- Write (author), revise, review, and approve technical documents, validation documents (protocols, reports), guidelines, policies, standard operating procedures (SOPs), specifications, forms, master batch records, control forms etc. according to regulatory guidelines (ICH, USP, etc.) for review by management, QA and/or customers. Assist in improving or creating templates as needed
- Write (author), revise, and review quality systems documents including investigation reports, non-conformance reports, corrective and preventive action reports, root cause analysis, audit reports, gap analyses, and risk assessments.
- Complete all assigned documentation in a timely fashion while ensuring consistent high quality and compliance with Good Manufacturing Practices (GMP).
- Conduct research and collect all necessary information to support documents being generated.
- Assist with mapping of various processes and identify non-value adding tasks that can be improved in order to achieve better work efficiencies
- Coordinate various project related activities to ensure on time delivery of the project
- Coordinate the timely completion of QMS documents and ensure department KPIs are met at all times
- Initiate and present change controls in the change control committee, to implement/revise/improve programs/documents and methods and monitor completion of all work in a timely fashion. Follow up to close change controls
- Initiate CAPAs as required and follow up through successful implementation and effectiveness checks.
- Support, as needed, the documentation of items required for new equipment purchases and installation (quotes, URS, change control, SOPS, STMs, forms, IQ/OQ/PQ, etc.)
- Coordinate and monitor completion of documents with coworkers within the manufacturing. Act as point of contact for other departments and team members for matters related to documentation.
- Assist with continuous improvement initiatives
- Complete all other assigned duties, as requested.

**Experience Necessary**
- B.Sc. in Chemistry, Biochemistry, Biotechnology, or a related discipline.

**What You Bring To The Role**
- Has strong verbal and written communication skills.
- Excellent grammar and composition.
- Efficient writer; able to quickly produce well-organized, logical, scientifically sound, comprehensive, and easy-to-follow documents.
- Efficient writer; able to quickly produce well-organized, logical, scientifically sound, comprehensive, and easy-to-follow documents.
- Proficient in using various types of computer software including advanced level skills with Microsoft Word and Excel
- Fast learner with an aptitude for learning and researching new innovative approaches used within the industry
- Demonstrated understanding of GMP regulations.
- Good time management skills.
- Ability to work both independently and cooperatively in a team environment.
- Flexibility in work schedule to support a 7-day work week

**AtomVie offers**:

- Group Health & Dental Benefits (from day 1)
- RRSP Matching
- Paid Sick & Discretionary Days
- Parking Allowance
- Perkopolis
- Employee Assistance and Wellness Programs
- Training & Career Development
- Opportunity for long-term growth
- Join a passionate team making a difference in patients’ lives

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients.

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