Quality Assurance Associate II
2 weeks ago
Seegene USA, Inc. is a global leader in molecular diagnostics, dedicated to advancing science and developing innovative technologies. We are seeking a highly motivated and detail-oriented Quality Assurance Associate II to join our team.
Job Summary:The Quality Assurance Associate II will play a critical role in ensuring the quality of our products and services. This includes assisting in the development and implementation of quality policies and procedures, maintaining records and revision control, and participating in audits and investigations.
Key Responsibilities:- Assist in the improvement of SOPs, work instructions, policies, procedures, job aids, and business process communications
- Participate in documenting reports for tracking and trending of events
- Maintain records and revision control in the SGUS electronic Quality Management System (eQMS)
- Participate in evaluation of customer complaints, initiation of CAPA Investigations, tracking and trending of events
- Aid in maintaining training and safety documentation for employee records and audits
- Perform Verifications, Inspections, and maintaining equipment records and certifications
- Learn the use of process mapping techniques, lean, or Six Sigma process improvement methodology to reduce waste
- Participate in corrective action investigations, process improvement teams, audits, customer visits and strategy discussions
- Contribute to Supply chain audits, client audits, and internal process audits with the Quality Manager
- Assist in documenting minutes for audit report write-ups
- Bachelor's degree in engineering or science related fields
- 2 years prior experience in Quality Assurance or Quality related field
- Must be familiar with Quality Standards. Experience with Good Manufacturing Practices (GMP), FDA Quality Systems Requirements (21 CFR Part 820), and ISO standards (i.e. ISO 13485)
- Demonstrated experience working with contract manufacturers, suppliers, or distributors
- Proficiency in Microsoft Office
- Experience in quality management systems
- Experience with Diagnostic Labs, Life Science, Biopharma or related business
- Understanding of GMP regulations
- Experience with eQMS (such as Master Control, Greenlight Guru, Veeva, TrackWise, etc.)
Seegene USA, Inc. is an equal opportunity employer. We are committed to creating a diverse and inclusive work environment that values and respects all employees. We do not discriminate against employees or applicants on any legally protected basis, including, but not limited to, race, color, religion, gender, gender identity, marital status, sexual orientation, national origin, ancestry, veteran's status, age, or disability which does not interfere with an individual's ability to perform the essential functions of his or her job position with or without reasonable accommodation.
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Irvine, California, United States Seegene USA Full time{"title": "Quality Assurance Associate II", "description": "Job SummarySeegene USA, Inc. is a global leader in molecular diagnostics, and we are seeking a highly skilled Quality Assurance Associate II to join our team. As a Quality Assurance Associate II, you will play a critical role in ensuring the quality of our products and services, and contributing to...
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