Rena Lam Email & Phone Number

California, United States

San Francisco, California, Us

-Reported to VP, Quality-Regulatory: Built and managed a QA team responsible for the development, implementation, and maintenance of various QMS to US CFR 820, EN ISO 13485:2016, ISO 14971:2019, and EU MDR 2017/745 requirements.-Incorporated existing regulations and standards to a young industry: Successfully received EN ISO 13485:2016 certification for a fully remote, Software as Medical Device (SaMD) company; One of the first in the industry.-Ensuring comprehensive incorporation of quality in product design from start to finish: Core QA/Regulatory member in product development teams to provide quality and regulatory input, ensuring regulatory requirements and standards are rooted into software design, development, testing, release, and documentation.-Active participation with Engineering team collaboration: Participation in bimonthly Agile sprint planning, JIRA ticket drafting of regulatory needs, software QA testing documentation review and approvals, technical product planning, and lessons learned sessions.Hands-on quality system building: Designed and implemented quality systems and EU MDR technical documentation components, such as Change Control, Complaint Handling, Post Market Surveillance, and others.-Experienced auditor and auditee: Responsible for executing internal audits and representing the company for audits by regulatory bodies (FDA), notified bodies (ISO), and business partners (pharmaceutical).

-Responsible for the success of the Software Quality Assurance, Operations Quality Assurance, and Environmental Health and Safety teams.-Foster a collaborative culture between personnel and departments to increase cross pollination of ideas and knowledge, leading to more comprehensive planning and execution of projects and goals.-Main quality assurance representative for corporate integration projects to ensure South SF regulatory needs are met while planning and executing the adoption of corporate infrastructure.-Using Hoshin Kanri, managing the department of 8, to ensure Quality Management Systems are built, operational, and continuously improved while also ensuring company goals are met.-Provide QA guidance to various stakeholders in areas of regulatory compliance to CLIA, CAP, and NYS.-Led the coordinating, compiling, and reviewing of NYS LDT submission packets, leading to 1 successful LDT full approval and 1 successful assay modification.-Train various Operations personnel in quality tools such as 5S, LEAN, Kaizen, and Process Flow Maps to drive continuous improvement in Quality Management Systems, lab processes, and process development.

-Using Hoshin Kanri to manage a team of 5 to ensure Quality Management Systems are built, operational, and continuously improved while also ensuring company goals are met.-Main quality assurance representative for corporate integration projects to ensure South SF regulatory needs are met while planning and executing the adoption of corporate infrastructure.-Train various laboratory personnel in quality tools such as 5S, LEAN, Kaizen, and Process Flow Maps to drive continuous improvement in Quality Management Systems, lab processes, and process development.-Provide QA guidance to various stakeholders in areas of regulatory compliance to CLIA, CAP, and NYS.-Lead architect in developing and implementing Change Control system.-Led the coordinating, compiling, and reviewing of NYS LDT submission packets, leading to 1 successful LDT full approval and 1 successful assay modification.-Led inter-departmental efforts to a successful NYS audit in July 2017 and CAP Audit in Feb. 2018.

-Manage a team of 1 Sr. Quality Engineer, 1 Quality Engineer, 1 Sr. QA Specialist, 1 Sr. QA Associate, and 1 Sr. Technical Writer/Document Control to ensure Quality Management Systems are built, operational, and continuously improved.-Promote and guide continuous improvement in Quality Management Systems, Lab Processes, and Process Development.-Provide QA guidance to various stakeholders in areas of regulatory compliance to CLIA, CAP, and NYS.-Lead architect in developing and implementing Change Control system.-Lead for coordinating, compiling, and reviewing NYS LDT Submission Response packet.-Led inter-departmental effort in a successful NYS Audit in July 2017.-Led inter-departmental effort in a successful CAP Audit in Feb. 2018.

San Francisco, Ca, Us

-Lead QA in areas of process validation, change control, and technology transfer in a CAP, CLIA, and NYS accredited NGS laboratory. Responsibility include the continuous improvement of systems, provide regulatory input, and ensure all documentation meets regulatory standards.-Led and developed the addition of a QA module to Invitae's New Hire Orientation.-Successfully received CAP auditors and passed the re-certified audit.-Planned and successfully executed the transition of document control systems from Veeva Vault to MediaLab.

San Jose, Ca, Us

-Lead QA representative in areas of equipment qualification (IOPQ), procedures drafting and approval, records review and approval, and personnel training for clinical lab planning and launch.-Lead QA representative for ISO 17025 accredited NGS Lab in areas of drafting guidance, personnel training, and document review and approvals of: procedures, deviation reports, CAPA investigations, change control, materials expiration and obsolete reports, and other quality system documentation.-Designed, implemented, and oversee the Lab’s NGS proficiency testing (PT) program in accordance to ISO 17025, CLIA, CAP, and New York (NY) state requirements.-Continuously improve Document Control, Change Control, and other lab quality management systems, utilizing LEAN Six Sigma, Kaizen, Waste Management, Process Flow Diagrams, and other tools.

-Specializes in the College of American Pathologists (CAP) and ISO 17025, 15189 accreditation systems.-Authored Quality Manual and some quality policies according to the ISO 17025, 15189, CLIA, and CAP standards.-Designed, implemented, and organized the document control, CAPA, PT, and chemical waste handling systems.-Performed gap analyses and led laboratory preparation efforts for accreditation and audit visits.-Performed internal audits and received auditors for external audits.-Trained Lab personnel on GDP and quality management systems.

-Lead Technical Representative responsible for accommodating VIP guests and providing lab tours.-Recruited, trained, coordinated, and organized a team of 12 for events such as recruitment, lab tours of up to 100 people for annual International Conference on Genomics participants, student field trips, and other large scale lab tours.-Participated in discussions and project planning meetings with clients.-Hong Kong representative and occasional translator for large pharma related visitors in Hong Kong and Shenzhen sites.

-Reviewed the applicability of quality management system documents from BGI Shenzhen (Headquarters) and translated for local use.-Designed, implemented, and maintained document control system.-Spearheaded the implementation of 5S organizational system.-Coordinated and organized laboratory preparation for accreditation and audit visits.-Received auditors for external audits.

-Troubleshot Illumina HiSeq 2000 DNA sequencers when irregularities and malfunctions occur during a run.-Worked with Illumina Field Application Scientists and Field Service Engineers to communicate our findings and develop solutions.-Rotated through various lab platforms and trained in hands-on operation, from library preparation to operating the HiSeq 2000 DNA sequencers.-Drafted various proposals, ranging from lab design to marketing plans for company projects.

-Translated English-Chinese between clients, the Director, and other Chinese speaking personnel during project discussions.-Assisted Project Managers and followed up with preproduction and bulk production processes.-Performed daily factory floor rounds to influence better product quality, remove various types of waste, and improve personnel performance.

Berkeley, Ca, Us

-Prepared and updated handbooks, fliers, and information sheets that were given to visiting ESL students.-Assisted visiting students when they have questions or concerns. -Translated important information (between Cantonese/Mandarin and English) for visiting student if she/he had difficulty understanding.

Berkeley, Ca, Us

-Prepared and updated handbooks, fliers, and information sheets that were given to visiting ESL students.-Assisted visiting students when they have questions or concerns. -Translated important information (between Cantonese/Mandarin and English) for visiting student if she/he had difficulty understanding.

Ba, Molecular And Cell Biology- Immunology: Infectious Diseases

Master Of Science, Biochemical And Biomedical Sciences