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The QA Project Coordinator will be key player in ensuring quality and regulatory documents are organized and stored in an efficient and effective manner. The ideal candidate will have experience in a regulated environment, writing and reviewing SOPs, maintaining/ managing document control systems, and general QA / QC experience. Working knowledge of quality management system (QMS) is required.
Key Responsibilities
Create and maintain document filing and organizing systems that are both effective and efficient
Ensure proper organization and security of documents (paper and electronic)
Prepare reports on quality management system performance
Track due dates for deviations/ incidents, CAPA, customer complaints and OOS investigations
Reviews internal audit reports
Provide technical expertise to assist with continuous improvement initiatives and process development activities including development of quality assurance programs and SOPs, as directed
Working along with other members of the QA team, develop and improve quality programs and processes
Lead QA special projects and initiatives as needed
Provide support during inspections and third-party audits as required.
Contribute to overall Quality Department goals
Other duties as assigned
Requirements
Bachelors degree or higher in relevant science (Quality Assurance, Food Science, Pharmaceutical Science or related field)
3-5 years quality management systems experience
Experience with electronic quality management system software preferred
Experience authoring and/or reviewing quality documents or records in a regulated environment
Experience in third party audits
Must demonstrate proficiency in computer skills and Microsoft Office Suite (Word, Excel, PowerPoint and Outlook)
Highly organized and detail-oriented with strong follow-up skills to manage large volumes of documentation
Excellent written and verbal communication skills
Computer and Technology Knowledge
- Windows
- File management software
- Spreadsheet software
- Office Suites
Essential Skills
- Reading text
- Document use
- Numeracy
- Writing
- Oral communication
- Working with others
- Problem solving
- Decision making
- Critical thinking
- Job task planning and organizing
- Finding information
- Computer use
- Continuous learning
- Significant use of memory
Transportation/Travel Information
- Public transportation is not available
Area Of Specialization
- Development of production processes
- Development Of Quality Assurance Programs
Work Conditions and Physical Capabilities
- Fast-paced environment
- Tight deadlines
- Handling heavy loads
- Attention to detail
- Ability to distinguish between colours
- Combination of sitting, standing, walking
Security and Safety
- Criminal record check (abstract)
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