Job Description

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 and Scientific Writer (QC/AD) is an advanced- level writer with GMP experience in quality systems (document control, investigations, root cause analysis, and risk assessments), quality control testing of pharmaceutical drug products, method transfer, and method validation. They provide practical, technical and operational support to the activities of the scientists, analysts and technicians by authoring, editing, or providing input on all manner of documents associated with successful laboratory operations.

Location: Hamilton (Hybrid)

What You Will Do

• Plan, implement and successfully complete assigned documentation for Analytical Development and Quality Control projects and tasks in a timely fashion while ensuring consistent high quality and compliance with Good Manufacturing Practices (cGMP).
• Initiate change controls and present CCs in change committee to implement/revise/improve programs and methods and monitor completion of all work in a timely fashion. Follow up to close change controls on time.
• Conduct research and collect all necessary information to support documents being generated.
• Write (author), revise, review, and approve technical documents, validation documents (protocols, reports), guidelines, policies, STMs, SOPs, specifications, forms, master batch records, etc. according to regulatory guidelines (ICH, USP, etc.) for review by management, QA and/or customers. Provide peer review and provide input for co-workers. 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.
• 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.), including hands-on work in the lab or at instruments to run trials or to observe proposed procedures.
• Assist QA on vendor qualification tasks.
• Provide back-up support for technical review of laboratory records and notebook; create the material or batch release certificate of analysis, as needed.
• Coordinate and monitor completion of documents with coworkers within the quality team (quality assurance, quality control, analytical development). Act as point of contact for other departments and team members for matters related to documentation.
• Provide training in technical writing and data presentation skills for team members.
• Prepare presentations for internal and external (client) review to summarize documentation status and participate in client meetings if required.
• Participate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed by the QC/AD team.
• Adhere to GMP regulations by maintaining complete training records pertaining to all aspects of routine operation and ensure compliance with regulatory bodies.
• Conduct all work in accordance with AtomVie Standard Operating Procedures (SOPs) and raise any deviations immediately to the attention of Lab Management and Quality Assurance.
• Maintain a working understanding of and ensure timely review of updates for the regulations and guidelines.
• Document and communicate the compendia changes to the team.
• Conduct self and all activities with the highest level of competency and reliability, follows company policies and procedures and shows support for the organization’s goals and values.

What You Bring to the Role

• 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.
• Proficiency in using various types of computer software (Word, Excel, PowerPoint, etc.)
• Demonstrated understanding of GMP regulations.
• Good time management skills.
• Experience in the laboratory (bench-level) testing of materials and products using HPLC, GC, TLC, etc.
• Experience working with sterile products, working in a BSL2 laboratory, and knowledge of microbiological testing (Bioburden, Sterility, Bacterial Endotoxins) is an asset.
• Ability to work both independently and cooperatively in a team environment.
• Willingness to work in a facility that handles radioisotopes and radiopharmaceuticals.
• understanding for unique challenges of radiopharmaceutical industry with respect to shifts, hours, and overtime.

Requirements

• B.Sc. in Chemistry, Biochemistry, Biotechnology, or a related discipline.
• M.Sc. is preferred.
• 3-5 years’ hands-on experience in a pharmaceutical GMP environment with proficiency in quality control testing and/or HPLC method development, validation and stability programs
• Flexibility in work schedule to support a 7-day work week (morning and day shifts)
• Frequent walking between buildings and laboratories or transit between sites.

AtomVie Offers

• Group Health & Dental Benefits (from day 1)
• RRSP Matching Program
• Perkopolis
• Employee Assistance and Wellness Programs
• Parking Allowance

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. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.

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