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 build out and implement a Quality Management System (QMS) from the ground up, focusing initially on ISO 9001 certification and transitioning 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 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 or 13485) with setup experience preferred.
- 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 Hayward, CA, Paragon Genomics is a dynamic and growing company developing and commercializing breakthrough target enrichment solutions for Next-Generation Sequencing (NGS). We are building a team of talented scientists, engineers and business professionals that thrive in a collaborative entrepreneurial environment. Our patented CleanPlex® technology solves the urgent throughput and efficiency bottlenecks of NGS target enrichment workflow and is applicable to many fast-growing markets in the genomics space. 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.