Overview
Sr. IVD QA Manager Jobs in San Francisco, CA at Veracyte
Luminary Life Sciences (NextGen Genetics) is illuminating the path to parenthood for individuals and families by pioneering a comprehensive suite of life science services tailored to meet the specialized needs of patients throughout every step of the reproductive health journey. Our vision is to empower patients and health care professionals by offering innovative, customer-centered solutions that provide support from pre-conception to post-birth.
The QA/QC Specialist is responsible for monitoring, inspecting, and proposing measures to correct or improve all products and processes related to the collection, processing, storage, and dissemination of pre-implantation genetic tests in accordance with pertinent regulations and established quality standards. Working closely with the General Manager, the laboratory, operations, and genetics team leads, the QA/QC Specialist will be responsible for managing all licenses, certifications, and standardization programs required by Luminary Genetics to operate in accordance with established regulations and standards.
Full-Time 75K-85K, Day Time Hours
Essential Job Responsibilities:
Develop and implement quality control and assurance policies and procedures.
Conduct inspections, tests, and audits to ensure compliance with internal and external standards.
Monitor production processes to identify deviations or issues and recommend corrective actions.
Document quality assurance activities and create audit reports.
Investigate client/patient complaints and non-conformance issues.
Coordinate with other teams to ensure consistent quality standards are met across operations.
Review and update quality documentation, such as SOPs, work instructions, and protocols.
Support continuous improvement initiatives and process optimization.
Ensure compliance with applicable regulatory and safety standards
Train staff on quality procedures and best practices.
Ensure that all licenses and certifications are maintained accordance with established standards and regulations.
Communicate with designated regulatory bodies related to new or existing licenses and certifications.
Additional responsibilities as deemed necessary.
Minimum Qualifications:
Bachelor’s degree in Quality Management, Engineering, Science, or a related field.
2+ years of experience in quality assurance/quality control or a similar role.
Strong knowledge of quality assurance methodologies, tools, and processes.
Familiarity with laboratory regulatory standards
Excellent analytical, problem-solving, and organizational skills.
Strong communication and interpersonal abilities.
Proficiency in MS Office and quality management systems (QMS).
Knowledge, Skills, and abilities:
Computer proficiency required.
Excellent verbal & written communication skills.
Ability to work as part of a multi-disciplinary team.
Excellent interpersonal skills and ability to build and maintain effective working relationships.
Flexibility and willingness to learn at all times
Excellent multi-tasking abilities
Physical Requirements:
The physical demands listed below are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the position. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions. A request for a reasonable accommodation should be made in writing and delivered to the Talent team.
Education
Preferred
Bachelors or better
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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Title: Sr. IVD QA Manager
Company: Veracyte
Location: San Francisco, CA
