The Senior Quality Assurance Specialist is responsible for supporting the operation of the Quality Management System processes and associated programs to achieve and maintain compliance with applicable regulations (CLIA, CAP, State DOHs, NYS, FDA, ISO 13485, GCLP) as well as supporting the necessary training associated with these regulations.
Essential Duties and Responsibilities
The Quality Assurance Specialist will be accountable for the following activities:
Assist with Veracyte's Quality Management Systems processes
Document Control Program: creation, approval, and maintenance of company Standard Operating Procedures, batch records, and specifications for materials/reagents used for Veracyte test assays,
Change Management Program: manage identification and tracking of changes to approved procedures, validated software and processes, and qualified equipment,
Approval process: assist with managing the approval processes for quality documents; collaborate with document reviewers to consolidate comments and resolve discrepancies,
Design and maintain templates used for the creation of documents, ensuring consistent use and application of templates by users,
Deviations/Non-conformances: Identify and track key deliverables associated with process events or changes to aid in implementing corrective actions,
Design Control Program: aid with tracking of product design changes, and approval of all design history files for laboratory developed tests (LDT's),
Internal Audit program: Assist with conducting internal audits to verify compliance with applicable Veracyte and CLIA/CAP requirements,
Quality Metrics: Perform trending analysis and reporting of quality indicators.
Supports all activities related to the clinical laboratory, including activities related to pre-analytical, analytical, and post analytical phases.
Work cooperatively in a team environment to maintain cross-functional and cross-site processes and procedural consistency for quality system records.
Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
Participate in projects that support continuous improvement efforts.
Assist with ensuring internal compliance with the QMS programs and activities for our CLIA-regulated Clinical Laboratory.
Analyze non-compliance issues to identify trends and propose resolutions.
Track and facilitate investigations in cross functional team discussions in support of closing non-conformances, change controls, and CAPAs.
Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies; State DOHs, CAP, NYS.
Support activities associated with the creation and maintenance of licenses, certificates, and permits.
Assist in supplier qualification and reassessment activities.
Support activities for future regulatory submissions.
Who You Are
You have a bachelor's degree in a biological sciences or clinical laboratory sciences with 5-8 years of relevant experience in a regulated, high complexity testing laboratory environment
CLIA Laboratory, IVD, LDT or medical device experience preferred
Experience working in Quality or a laboratory environment regulated by CLIA, CAP, NYSDOH, and FDA is preferred.
Experience in maintaining compliance with quality standards in a regulated clinical laboratory.
Practical and hands-on experience in Quality Management Systems; a minimum of 5 years of experience preferred.
Experience with document control, change control, deviations/nonconformances, and design control programs.
Experience working with MediaLab Quality software and equivalent platforms a plus.
Excellent problem-solving skills; demonstrated strength in tact and diplomacy with internal and external collaborators.
Ability to work independently and exercise good judgment.
Excellent interpersonal skills and ability to work with others in a positive and collaborative manner.
Excellent written and communication skills.
Excellent prioritization and organizational skills.
Understanding of CMS regulations related to laboratory testing is required.
What We Can Offer You
Veracyte is a growing company that offers significant career opportunities if you are curious, driven, customer-oriented and aspire to help us build a great company. We work collaboratively, offering you the opportunity to constantly learn from your colleagues - even those outside of your area of expertise. Here at Veracyte, we find fun, little ways to make it a great place to work - participate in our annual Halloween costume contest, treat yourself to the endless supply of PB&J sandwiches, and toast with colleagues as we celebrate milestones. We also offer conveniences such as an on-site workout room and free shuttle service from both BART and CalTrain. We are a company with a heart and believe in positively impacting the world beyond our doors by providing our product to those who cannot afford it through a financial assistance program. Veracyte seeks the best employees and works to create an environment where they can thrive, expand their knowledge and contribute at the highest level.