About the RoleThe Microbiology Technical Writer and Data Reviewer provides scientific, technical, and operational support to the Microbiology and Sterility Assurance team through authoring, reviewing, and managing GMP documentation, reviewing microbiological laboratory data for accuracy and compliance, and supporting quality system activities. The incumbent works closely with microbiologists to ensure technical documentation and laboratory records are complete, accurate, scientifically sound, and compliant with applicable GMP, data integrity, and regulatory requirements.
This role serves as a key resource for documentation management, technical writing, data review, investigation support, and continuous improvement initiatives within Microbiology and Sterility Assurance operations. The incumbent is expected to maintain a high standard of quality, professionalism, and scientific integrity while supporting timely completion of departmental objectives.
This posting is for an existing vacancy to support the expansion of the company.
Location: AtomVie Global Radiopharma Inc,
Hamilton ON (Onsite). What You Will Do- Perform independent review of microbiology laboratory records for completeness, accuracy, traceability, and compliance with Good Documentation Practices (GDP).
- Review microbiological test documentation, including Sterility testing, Bioburden testing, Growth promotion testing, Environmental monitoring records, Microbial identification records, Method suitability studies, etc..
- During review of the data, ensure that:
- Required Test methods, Protocols and Standard Operating Procedures (SOPs) were followed by microbiologists.
- The instruments used are qualified for use, calibrated and verified.
- Ensure compliance of results with specifications.
- Follows up with microbiologists to ensure all necessary corrections are completed in accordance with Good Documentation Principles (GDP) and/or 21 CFR Part 11 requirements (for electronic records) in a timely manner.
- Verify calculations, data transcription, attachments, references, and supporting documentation.
- Ensure laboratory records are completed in accordance with approved procedures and regulatory expectations.
- Perform documentation quality reviews prior to QA approval.
- Support responses to client requests for microbiology data and technical information.
- Draft, revise, and maintain: Standard Operating Procedures (SOPs), Work instructions, Test methods, Validation Protocols and Reports, Technical reports, periodic Trend Reports, Investigation reports, CAPA documentation, Client reports, etc.
- Collaborate with microbiologists to convert technical data into clear, concise, and scientifically accurate documentation.
- Compile microbiology data for drafting the summary reports.
- Coordinate document updates resulting from change controls, investigations, CAPAs, process improvements, and regulatory changes.
- Track microbiology documentation deliverables and reporting commitments.
- Support project teams by coordinating documentation timelines and review cycles.
- Assist with preparation and organization of documentation required for audits and inspections.
- Ensure all reviewed documentation complies with GMP, GDP, ALCOA+, and data integrity requirements.
- Review records for compliance with: Health Canada cGMP, FDA cGMP regulations, EU GMP Annex 1, USP and EP microbiological requirements, Internal quality system procedures
- Support investigations related to documentation errors, data discrepancies, and quality events.
- Participate in Change Controls, CAPAs, Non-Conformances, and Investigations from a documentation and compliance perspective.
- Maintain inspection readiness of microbiology documentation and records.
- Identify opportunities to improve document quality, efficiency, and compliance.
- Serve as the departmental subject matter resource for documentation standards and best practices.
- Provide guidance to microbiologists regarding documentation requirements and record completion expectations.
- Support training of the team members on Good Documentation Practices and data integrity requirements.
- Promote consistency across microbiology documentation and reporting processes.
- Other duties as assigned.
What You Bring To The Role- Strong scientific writing and editing skills.
- Excellent understanding of GMP documentation requirements.
- Working knowledge of microbiological testing and laboratory operations.
- Strong attention to detail and record review capabilities.
- Strong technical writing, grammar, and document formatting skills.
- Experience with investigations, CAPAs, change controls, and quality systems.
- Proficiency in Microsoft Word, Excel, PowerPoint, and electronic quality management systems.
- Strong organizational and project coordination skills and ability to meet operational deadlines.
- Ability to work effectively with scientific and cross-functional teams.
- Flexibility in schedule to support a 24/7 operational environment.
Requirements- Bachelor of Science in Microbiology, Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
- Minimum 2 to 3 years of experience in a GMP-regulated pharmaceutical, biotechnology, radiopharmaceutical, or related environment.
- Experience reviewing scientific or laboratory documentation.
- Experience authoring technical reports, SOPs, investigations, protocols, or validation documentation.
- Experience supporting pharmaceutical microbiology, sterility assurance, quality control, or quality assurance functions preferred.
Compensation: Annual salary starts at $79k.
AtomVie Offers- Group Health & Dental Benefits (from day 1)
- RRSP Matching Program
- Perkopolis
- Employee Assistance and Wellness Programs
- Transportation/Parking Allowance
AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.
