Senior Quality Assurance Specialist at Natera

Austin, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jul, 26

Salary

99400.0

Posted On

24 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality assurance, CAPA, Nonconformances, Compliance, Document control, Internal audit, Complaint investigations, Facility management, Regulatory compliance, Stakeholder engagement, Vendor management, Data analysis, Problem solving, Communication, Clinical laboratory operations, Biotech industry knowledge

Industry

Biotechnology Research

Description

Are you a quality-driven professional who thrives in a fast-paced environment, tackles complex issues head-on, and pivots seamlessly when priorities shift? We’re looking for a highly motivated, experienced Quality Assurance professional to lead and manage critical quality event processes, including complaints, nonconformances, CAPAs, and deviations. The Senior Quality Assurance Specialist oversees the day to day management and operations of the facility, products and vendors. Through outstanding communication, effective problem solving, and active management of ambiguous situations, the Senior Quality Assurance Specialist ensures product safety, product quality and compliance with all relevant procedures, state and federal regulations and customer expectations. Ensures smooth and safe operations of the storage facility through stakeholder and vendor engagement. PRIMARY RESPONSIBILITIES: Operation and monitoring of facility, product, equipment and associated software. Timely responses to resolution of alarm notifications from the facility systems and product storage systems. Support in product inventory activities. Execution of product movement during emergencies and planned maintenance. Maintenance of equipment and safety equipment to ensure quality product storage and employee safety. Host and lead state and federal inspectors during inspections. Continuously evaluate progress toward objectives adapting them to meet customer and business needs. Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors. Serve on Teams such as CAPA, Deviations, and Nonconformances; represents or serves as escalation for Quality on Core Teams. Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies. Support the set up and maintenance Quality Systems for Document Control, CAPA, Internal Audit, and Complaint investigations. Comply with all quality policies, procedures, and practices through consistent application of sound quality assurance principles. Other duties as assigned. This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job. Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire. QUALIFICATIONS: Bachelor's degree in science, engineering, medical technologist, other relevant discipline, or equivalent required. 5+ years of work experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience KNOWLEDGE, SKILLS, AND ABILITIES: Prior quality or operational experience in a medical setting is a plus. The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Austin, TX $79,500—$99,400 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Responsibilities

The Senior Quality Assurance Specialist manages critical quality event processes including CAPAs, nonconformances, and complaints while overseeing facility and product safety. They also lead state and federal inspections and collaborate with stakeholders to implement quality improvements.