What are the responsibilities and job description for the GMP Operational Quality Specialist position at cGxPServe?
Job Summary:
We are seeking an experienced GMP Operational Quality Specialist to join our team on a contract basis, focusing on compliance, quality processes, documentation control and quality control activities for our medical device manufacturing operations. The ideal candidate will have a strong background in Quality Assurance (QA) within the medical device (or similarly regulated) industry. This candidate will assist in incoming material inspections, supporting document control, quality system compliance, and other quality activities as needed. This role is ideal for someone with a keen eye for detail, a commitment to quality, and a desire to grow within the medical device field.
Key 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:
- 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.
- 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.
Qualifications:
- Education:
- Bachelor's degree in Engineering, Quality Assurance, or a related Science field.
- Experience:
- 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.
Contract Duration:
- 12 months, with possibility of an extension
