What are the responsibilities and job description for the GMP Operational Quality Specialist position at Katalyst Healthcares and Life Sciences?
Responsibilities :
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.
Document Control :
ssist 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.
Quality System Oversight :
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.
Other Duties as Assigned :
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.
Requirements :
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).
Skills and Competencies :
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.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a GMP Operational Quality Specialist?
Sign up to receive alerts about other jobs on the GMP Operational Quality Specialist career path by checking the boxes next to the positions that interest you.
