Tiara Shankling, MSRA
Senior Quality Assurance Specialist at Sequoia Consulting Group,LLC- Claim this Profile
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Bio
Credentials
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Master of Science
Northeastern UniversityJul, 2021- Nov, 2024 -
Access 2019 Essential Training
LinkedInSep, 2020- Nov, 2024 -
Experiential Network
Northeastern UniversitySep, 2020- Nov, 2024
Experience
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Sequoia Consulting Group
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United States
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Biotechnology Research
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100 - 200 Employee
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Senior Quality Assurance Specialist
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Oct 2021 - Present
Medical Device Client, Regulatory Affairs Specialist-Post Market Surveillance •Supported regulatory submissions activities such as Periodic Safety Update Reports (PSUR) and Post-Market Performance Follow-Up (PMPF) Plan and Report for a medical device company to meet the regulatory standards for post-market surveillance. •Extracted and reviewed data sets from public databases to populate tables, author reports, and identify safety… Show more Medical Device Client, Regulatory Affairs Specialist-Post Market Surveillance •Supported regulatory submissions activities such as Periodic Safety Update Reports (PSUR) and Post-Market Performance Follow-Up (PMPF) Plan and Report for a medical device company to meet the regulatory standards for post-market surveillance. •Extracted and reviewed data sets from public databases to populate tables, author reports, and identify safety issues. Pacific Biosciences Client, Technical Writer •Authored technical reports for a biotechnological company to prepare for ISO Certification audit. •Attended meetings to clarify document pending items and receive feedback when applicable. Medical Device Client, Regulatory Affairs Specialist •Collected and organized documents stored in the client’s QMS system necessary for MDR submission. •Attended meetings to clarify document pending items and receive feedback when applicable. Genomic Diagnostics Client, Quality Specialist •Lead team meetings to discuss open non-conformance reports (NCRs) to identify possible root causes by using quality tools such as the Fishbone diagram and 5 Why's. •Manage NCR closures by authoring open NCR’s investigations, root causes, and potential process improvements. Cancer Detection Diagnostics Client Quality Specialist •Authored SOPs, corresponding logs and forms, and process templates to support laboratory activities such •Created a complete documentation package for IQCP and Software Validation with supporting Excel monitoring sheets and supporting documents. Clinical-Stage RNA Therapeutics Client, Technical Writer •Authored technical reports for a biotechnological company during its pre-clinical stages. •Attended meetings to clarify document pending items and receive feedback when applicable. Show less Medical Device Client, Regulatory Affairs Specialist-Post Market Surveillance •Supported regulatory submissions activities such as Periodic Safety Update Reports (PSUR) and Post-Market Performance Follow-Up (PMPF) Plan and Report for a medical device company to meet the regulatory standards for post-market surveillance. •Extracted and reviewed data sets from public databases to populate tables, author reports, and identify safety… Show more Medical Device Client, Regulatory Affairs Specialist-Post Market Surveillance •Supported regulatory submissions activities such as Periodic Safety Update Reports (PSUR) and Post-Market Performance Follow-Up (PMPF) Plan and Report for a medical device company to meet the regulatory standards for post-market surveillance. •Extracted and reviewed data sets from public databases to populate tables, author reports, and identify safety issues. Pacific Biosciences Client, Technical Writer •Authored technical reports for a biotechnological company to prepare for ISO Certification audit. •Attended meetings to clarify document pending items and receive feedback when applicable. Medical Device Client, Regulatory Affairs Specialist •Collected and organized documents stored in the client’s QMS system necessary for MDR submission. •Attended meetings to clarify document pending items and receive feedback when applicable. Genomic Diagnostics Client, Quality Specialist •Lead team meetings to discuss open non-conformance reports (NCRs) to identify possible root causes by using quality tools such as the Fishbone diagram and 5 Why's. •Manage NCR closures by authoring open NCR’s investigations, root causes, and potential process improvements. Cancer Detection Diagnostics Client Quality Specialist •Authored SOPs, corresponding logs and forms, and process templates to support laboratory activities such •Created a complete documentation package for IQCP and Software Validation with supporting Excel monitoring sheets and supporting documents. Clinical-Stage RNA Therapeutics Client, Technical Writer •Authored technical reports for a biotechnological company during its pre-clinical stages. •Attended meetings to clarify document pending items and receive feedback when applicable. Show less
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Bridge Diagnostics
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Senior Quality Assurance Specialist
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Feb 2021 - Oct 2021
Manage or support CAPA, training, document control, and other quality owned processes. Develop, track and trend Quality metrics as required Perform Document Control activities as required Leading and/or contributing to system, test method, quality assurance, and operational process improvement projects Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per CLIA, CAP, ISO and other regulatory agencies, as applicable Manage or support CAPA, training, document control, and other quality owned processes. Develop, track and trend Quality metrics as required Perform Document Control activities as required Leading and/or contributing to system, test method, quality assurance, and operational process improvement projects Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per CLIA, CAP, ISO and other regulatory agencies, as applicable
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AIVITA Biomedical, Inc.
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United States
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Biotechnology Research
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1 - 100 Employee
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Lead Quality Assurance
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Nov 2020 - Feb 2021
Ensures the product being released is up to industry and company standards. Evaluates the team throughout the life of the project to identify areas where improvement can be made. Improved the Document Control, Training, and Equipment Monitoring process by selecting, implementing, and maintaining an electronic QMS software.
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QA Associate II
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Sep 2018 - Nov 2020
Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required. Ensures that the sponsor and clinical sites are adhering to protocol requirements Monitors training documents to ensure compliance with all applicable policies and procedures. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the… Show more Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required. Ensures that the sponsor and clinical sites are adhering to protocol requirements Monitors training documents to ensure compliance with all applicable policies and procedures. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs. Ensures that the facility is compliant with FDA, FDB, other agency requirements.
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Grifols
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Spain
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Pharmaceutical Manufacturing
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700 & Above Employee
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Center Quality Manager
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Jan 2018 - Sep 2018
Independent level of quality inspection and control Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs. Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions… Show more Independent level of quality inspection and control Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs. Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required. Oversight of all aspects of internal and external audits including execution (if applicable). Continuously assesses, promotes, and improves the effectiveness of the quality systems Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment. Performs a review of the documentation of unsuitable test results and the disposition of the associated results. Documents, investigates, and performs root cause analysis for deviations and customer complaints Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required Reports compliance status to necessary parties. Ensures accuracy of donor files. Directs the maintenance and calibration of equipment and documentation of procedures. Ensures that Clinical Lab Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly conducted Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file. Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents. QM directs routine verification of the SOP and forms Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate. Show less Independent level of quality inspection and control Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs. Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions… Show more Independent level of quality inspection and control Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs. Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required. Oversight of all aspects of internal and external audits including execution (if applicable). Continuously assesses, promotes, and improves the effectiveness of the quality systems Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment. Performs a review of the documentation of unsuitable test results and the disposition of the associated results. Documents, investigates, and performs root cause analysis for deviations and customer complaints Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required Reports compliance status to necessary parties. Ensures accuracy of donor files. Directs the maintenance and calibration of equipment and documentation of procedures. Ensures that Clinical Lab Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly conducted Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file. Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents. QM directs routine verification of the SOP and forms Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate. Show less
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Hyland's Naturals
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United States
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Retail Health and Personal Care Products
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1 - 100 Employee
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Quality Assurance Lead
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Mar 2014 - Jan 2018
Perform Line Start-up for packaging and Manufacturing Operations Responsible for material labeling of Finished Goods, Bulk Product, Intermediates, Components and Raw Materials. Inspect incoming components, raw materials and finished goods for further processing Inspect outgoing Components, Raw Material, Bulk Product and Intermediates sent to Contract Manufactures Conduct label verification prior to issuing to Packaging. Organize and maintain retained samples. Assist with the… Show more Perform Line Start-up for packaging and Manufacturing Operations Responsible for material labeling of Finished Goods, Bulk Product, Intermediates, Components and Raw Materials. Inspect incoming components, raw materials and finished goods for further processing Inspect outgoing Components, Raw Material, Bulk Product and Intermediates sent to Contract Manufactures Conduct label verification prior to issuing to Packaging. Organize and maintain retained samples. Assist with the collection of retain samples for customer complaints Assist with the review of in-process batch records Verify DI water system operation daily reports Conduct line inspections, AQL and in-process checks for production and packaging operations. Organize/file batch records and other documents. Assist in investigations including adverse events. Conduct Self-Audits and assist with external audits. Inspect samples and release all incoming outsourced finished products. Work with Quality Control for management of any required tests. Create Rejection Reports and Deviation Reports as required. Assist in preparing specific SOPs. Perform work under cGMP environment. Show less Perform Line Start-up for packaging and Manufacturing Operations Responsible for material labeling of Finished Goods, Bulk Product, Intermediates, Components and Raw Materials. Inspect incoming components, raw materials and finished goods for further processing Inspect outgoing Components, Raw Material, Bulk Product and Intermediates sent to Contract Manufactures Conduct label verification prior to issuing to Packaging. Organize and maintain retained samples. Assist with the… Show more Perform Line Start-up for packaging and Manufacturing Operations Responsible for material labeling of Finished Goods, Bulk Product, Intermediates, Components and Raw Materials. Inspect incoming components, raw materials and finished goods for further processing Inspect outgoing Components, Raw Material, Bulk Product and Intermediates sent to Contract Manufactures Conduct label verification prior to issuing to Packaging. Organize and maintain retained samples. Assist with the collection of retain samples for customer complaints Assist with the review of in-process batch records Verify DI water system operation daily reports Conduct line inspections, AQL and in-process checks for production and packaging operations. Organize/file batch records and other documents. Assist in investigations including adverse events. Conduct Self-Audits and assist with external audits. Inspect samples and release all incoming outsourced finished products. Work with Quality Control for management of any required tests. Create Rejection Reports and Deviation Reports as required. Assist in preparing specific SOPs. Perform work under cGMP environment. Show less
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Dendreon
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United States
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Biotechnology Research
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300 - 400 Employee
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Quality Assurance
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2013 - 2014
Perform Batch Record preparation, issuance, and Batch Record review. Issuance of Controlled Labels and Forms. Perform Batch Record closure and Product Disposition. Review and approve GMP Controlled Documents including SOPs, Batch Records, and Test Methods. Ensure full GMP compliance for the disposition of Raw Materials and Components. Review, Approve, and Track Closure of Deviations, Non-Conformances, OOS, and Corrective Actions. Provide support for the Investigation and… Show more Perform Batch Record preparation, issuance, and Batch Record review. Issuance of Controlled Labels and Forms. Perform Batch Record closure and Product Disposition. Review and approve GMP Controlled Documents including SOPs, Batch Records, and Test Methods. Ensure full GMP compliance for the disposition of Raw Materials and Components. Review, Approve, and Track Closure of Deviations, Non-Conformances, OOS, and Corrective Actions. Provide support for the Investigation and Recall of non-conforming materials. Provide support for Investigations associated with Product Failures, Product Complaints, and BPDRs. Show less Perform Batch Record preparation, issuance, and Batch Record review. Issuance of Controlled Labels and Forms. Perform Batch Record closure and Product Disposition. Review and approve GMP Controlled Documents including SOPs, Batch Records, and Test Methods. Ensure full GMP compliance for the disposition of Raw Materials and Components. Review, Approve, and Track Closure of Deviations, Non-Conformances, OOS, and Corrective Actions. Provide support for the Investigation and… Show more Perform Batch Record preparation, issuance, and Batch Record review. Issuance of Controlled Labels and Forms. Perform Batch Record closure and Product Disposition. Review and approve GMP Controlled Documents including SOPs, Batch Records, and Test Methods. Ensure full GMP compliance for the disposition of Raw Materials and Components. Review, Approve, and Track Closure of Deviations, Non-Conformances, OOS, and Corrective Actions. Provide support for the Investigation and Recall of non-conforming materials. Provide support for Investigations associated with Product Failures, Product Complaints, and BPDRs. Show less
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Education
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2019 - 2021
Northeastern University
Master of Science - MS, Regulatory Affairs with a Concentration in Quality Assurance -
2016 - 2017
California State University-Dominguez Hills
Master of Science - MS, Quality Assurance -
2008 - 2012
Mount Saint Mary's University
Bachelor of Science (B.S.), Biology, General
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