Paragon Genomics is a fast-growing life sciences company developing advanced reagents and assay kits for next-generation sequencing (NGS). We are seeking a Quality Assurance (QA) Specialist that can help us transition our Quality Management System (QMS) from ISO 9001 to ISO 13485 certification. The QA Specialist ensures compliance with policies and procedures, serves as the main point of contact for customer quality audits, and provides quality system performance reports to management. This position will be expected to take a hands-on approach to activities in production and other processes, in order to identify and recommend opportunities for improvement. The QA Specialist will report to the CEO.
- Develop, implement, and maintain all QMS related activities and processes.
- Oversee supply chain verification and management, and conduct supplier audits.
- Develop and maintain the Quality Policy and related QMS elements (e.g. document control, change control, quality records, corrective & preventive actions, etc.).
- Prepare for and serve as the point of contact for all second and third-party audits.
- Define and document the responsibility, authority, and interrelation of key personnel managing the quality systems.
- Conduct scheduled reviews of key QMS indicators and performance of quality systems to assess their continued suitability, adequacy, effectiveness, and efficiency; issue periodic reports to management.
- Develop and maintain a customer complaint system to ensure complaints are investigated and resolved in a timely manner.
- Write the required policies, procedures, and protocols to ensure compliance with current regulations and best practices.
- Help to develop solutions for improving product quality and production and resolve customer product quality issues with the involvement of the R&D department.
- Communicate quality control information to all relevant organizational departments, outside vendors, or contractors.
- Ensure all quality standards and regulatory requirements are met – includes meeting ISO and OSHA standards, and maintain compliance with all local, state, and federal regulations.
- Additional duties as required
Qualifications and Background
- Bachelor of Science degree or equivalent in molecular biology, chemistry, or life science-related field.
- Minimum of 1 year of experience in a QA/QC leadership role.
- Strong working knowledge of quality systems, Good Manufacturing Practices (GMP), and ISO standards (9001 and 13485) with setup experience preferred.
- IVD and regulatory experience a plus.
- Understanding of risk management principles and ability to apply these principles in day to day quality management activities, quality and compliance issues, and business challenges.
- Critical thinker with the ability to read, analyze, and interpret technical data.
- Ability to lead, train, motivate, and work effectively within a team.
- Excellent oral and written interpersonal communication skills.
- Good conceptual, analytical, problem solving, planning, and organization skills, including demonstrated prior accomplishments.
- Ability to multi-task and wear multiple hats, assisting other departments as needed.
- Ability to prioritize and adapt to changing priorities while maintaining a high-quality standard.
- Proficient in Microsoft Office (especially Word, Excel, and Powerpoint).
- Ability to speak, write, and read English required.
- Ability to speak, write, or read Chinese a plus.
- Standing or sitting for long periods of time may be necessary
- Ability to travel internationally may be necessary
- Some lifting (up to 25 pounds) may be necessary
This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
Paragon Genomics Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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About the Company:
Headquartered in the San Francisco Bay Area, Paragon Genomics is a fast-growing precision medicine company. Our patented targeted sequencing technologies CleanPlex® DNA
, CleanPlex® RNA
, and CleanPlex® UMI
provide comprehensive solutions to precision diagnostics in oncology, infectious disease, inherited disease, reproductive health, neurology, cardiology, and many other applications. Our technologies and products have been adopted by hundreds of prominent Next-Generation Sequencing (NGS) labs globally. With our platforms, we can efficiently and rapidly produce unique and customized next-generation sequencing (NGS) assays to meet the needs of researchers, testing labs, and biopharma precision medicine projects.
The Company was selected by a distinguished panel into the California Life Science Association F.A.S.T. Program in March 2016 and was accepted into the prestigious Stanford StartX Medicine Accelerator Program in September 2016.
Paragon Genomics offers a competitive and comprehensive employee benefits package, including medical, dental, vision and life insurance, flexible spending account, 401K, paid time off, and stock options.