Documentation Coordinator
4 days ago
**Document Creation & Management**:
**Job Title**: Documentation Coordinator (Documentation Driver & Process Champion)
**Department**: Regulatory Affairs & Compliance
**Reports To**: Regulatory Affairs and Compliance Manager
**Job Summary**:
**Key Responsibilities**:
- Prepare, create, and maintain internal documentation, including SOPs, Preventive Control Plans (PCPs), batch records, and corrective action records.
- Write, revise, and review controlled documents to ensure accuracy, clarity, and compliance with regulatory standards.
- Manage Change Control documentation and batch-related deviations.
**Collaboration & Compliance**:
- Review technical documents through the eQMS (Veeva) or other electronic systems to ensure quality and compliance.
**Training Materials Development**:
- Develop training materials to support the Training Coordinator, ensuring complex information is distilled into clear, concise, and actionable content.
**Project Leadership**:
- Take ownership of documentation projects, driving them from start to finish with a focus on deadlines and quality.
- Assist with the close-out of CAPAs and quality events, ensuring all documentation is complete and accurate.
**Process Improvement**:
- Maintain templates and modules for technical documents to streamline processes and improve efficiency.
- Identify gaps in documentation processes and implement solutions to improve accuracy and turnaround times.
**Regulatory Support**:
- Support regulatory submissions by ensuring all required documentation is accurate, complete, and submitted on time.
- Stay up-to-date on industry regulations (e.g., GMP, GPP, Cannabis Act) and ensure documentation aligns with current standards.
**Qualifications**:
- **Education**: Post-secondary education in sciences, technical writing, or a related field.
- **Experience**:
- 2+ years of experience in a regulated industry (e.g., cannabis, pharmaceuticals, medical devices).
- Proven experience writing SOPs, PCPs, and other technical documents.
- Experience with Veeva or other cloud-based documentation systems is a plus.
**Skills**:
- Exceptional written and verbal communication skills.
- Strong attention to detail and ability to organize and prioritize work.
- Strong analytical and problem-solving abilities.
- Ability to work independently and drive projects to completion.
**Nice-to-Haves**:
- Experience with AI tools like ChatGPT for drafting or editing content.
- Knowledge of ICHQ10 processes and the Cannabis Act/Regulations.
- Project management or coordination experience.
- Bachelor’s degree in science or a related field.
- Experience in the cannabis, medical, or pharmaceutical industry.
**Key Attributes We’re Looking For**:
- **Proactive Leadership**: You take initiative and ownership of projects, ensuring they are completed on time and to the highest standard.
- **Problem-Solving Mindset**: You identify gaps and implement solutions to improve processes and outcomes.
- **Deadline-Oriented**: You thrive under pressure and consistently deliver high-quality work within tight timelines.
- **Collaborative Approach**: You work effectively with SMEs and stakeholders, ensuring alignment and timely delivery of information.
- **Attention to Detail**: You have a meticulous eye for detail and a commitment to producing accurate, compliant documentation.
**Working Conditions**:
- Fast-paced, deadline-driven environment.
- Occasional overtime may be required to meet project deadlines.
**How to Apply**:
**Job Types**: Full-time, Permanent
Pay: From $22.25 per hour
**Benefits**:
- Casual dress
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Vision care
Flexible language requirement:
- French not required
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
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