Technical Writer

AtomVie Global Radiopharma•Hamilton, ON

34d•CA$0 - CA$60,000•Onsite

About The Position

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases. We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare. About the Role The Technical Writer is an entry level position within the Manufacturing department. The incumbent provides practical, technical and operational support by authoring, editing and/or providing input on all manner of documents associated with successful manufacturing operations and also provide all needed support with continuous improvement projects. They work closely with the manufacturing team to monitor and ensure timely completion of all QMS tasks while ensuring consistent high quality, professionalism and integrity. The incumbent works cross-functionally with internal departments and external resources on technical writing related issues. The Technical Writer is a strong writer with excellent verbal and written English. The incumbent supports the radiopharmaceutical manufacturing teams through preparation of professionally written documents in compliance with GMP guidelines. This posting is for an existing vacancy to support the expansion of the company. Location: AtomVie Global Radiopharma Inc, Hamilton ON (Onsite)

Requirements

Communicates clearly in English; 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.
Advanced level skills with Microsoft Word and Excel
Proficient in using various types of computer software
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.
B.Sc. in Chemistry, Biochemistry, Biotechnology, or a related discipline.
1-3 years of technical writing experience, preferably within the pharmaceutical, biotechnology, or other related industry.

Responsibilities

Assist with continuous improvement initiatives
Coordinate various project related activities to ensure on time delivery of the project
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 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
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.
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.
Any and all other duties that support the mission of AtomVie.