What are the responsibilities and job description for the GMP Operational Quality Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
Incoming Material Inspection:
Incoming Material Inspection:
- Conduct inspections of incoming materials and components to ensure they meet established specifications and quality standards.
- Document inspection results, maintain inspection records, and communicate any deviations or non-conformances.
- Collaborate with suppliers and internal teams to address quality issues and perform root cause analysis.
- Assist in the management, organization, and distribution of quality documentation in accordance with regulatory requirements.
- Ensure that documents are accurately reviewed, approved, and updated as needed to maintain compliance.
- Support the creation and maintenance of standard operating procedures (SOPs) and work instructions.
- Help maintain the quality management system (QMS) to ensure compliance with relevant regulations and standards, such as ISO 13485 and FDA 21 CFR Part 820.
- Investigate quality issues, conduct root cause analysis, and implement corrective and preventive actions (CAPA) to resolve non-conformances.
- Provide support for various quality activities, including process improvement projects, risk assessments, and validation activities.
- Generate reports and metrics to monitor quality trends, identify risks, and provide insights for process improvement.
- Participate in team meetings, contribute ideas for continuous improvement, and stay informed on industry best practices.
- Bachelor's degree in engineering, Quality Assurance, or a related Science field.
- 2-3 years in a quality-related role, preferably in medical device manufacturing or a regulated industry (internship experience is acceptable).
- Familiarity with quality standards and regulatory requirements, including ISO 13485 and FDA regulations.
- Basic understanding of inspection techniques, document control processes, and quality management systems.
- Organizational and communication skills, with attention to detail and accuracy.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with QMS or ERP software is a plus.
