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QA Specialist
Natera Austin, TX
$85k-102k (estimate)
Full Time | Ancillary Healthcare 3 Months Ago
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Natera is Hiring a QA Specialist Near Austin, TX

The Quality Specialist participates 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 Quality Specialist 3 ensures safety, 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:

  • Oversight and Ownership of a Quality System (e.g. Change Control Lead including system and board lead)
  • Collecting and trending quality metrics
  • Assistance and leadership in CCRS, CAPAs, Deviations, SCAR, Complaints, and NCRs and filing completed records.
  • Partner to provide review and approval of Quality Records
  • Participate and contribute in Quality related meetings
  • Assist with obtaining documentation and supporting the team during audits
  • Work to help schedule Quality Events and Meetings
  • Stays current on applicable regulation and guidance from FDA, ISO13485, CLIA, CAP, etc
  • This role works with PHI on a regular basis both in paper and electronic form and has 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.
  • Must maintain a current status on Natera training requirements.
  • Employee must pass post offer criminal background check.
  • Performs other duties as assigned

QUALIFICATIONS:

  • Bachelor's Degree in Life Sciences, Engineering, Software or equivalent
  • 5 year of working experience in Biotech industry preferred Or a relevant combination of skills, education, and experience

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Minimum of 3 years of knowledge with cord blood, transfusion medicine preferred.
  • Experience with biologics, transfusion medicine, tissue/organ or cord blood/stem cells or equivalent.
  • Prior cryopreservation experience is a plus.
  • 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

$63,800—$79,800 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

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ancillary Healthcare

SALARY

$85k-102k (estimate)

POST DATE

01/27/2024

EXPIRATION DATE

04/24/2024

WEBSITE

natera.com

HEADQUARTERS

MIDDLETON, MA

SIZE

1,000 - 3,000

FOUNDED

2004

TYPE

Public

CEO

STEPHANIE BURKE

REVENUE

<$5M

INDUSTRY

Ancillary Healthcare

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If you are interested in becoming a QA Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Specialist for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on QA Specialist job description and responsibilities

Primarily, their job responsibilities includes evaluating adequacy of quality assurance standards.

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They devise sampling procedures and directions for recording and reporting quality data.

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Plan, conduct, and supervise test and inspection of materials and products to ensure quality is maintained.

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Analyze data to identify areas for improvement in the quality system.

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Develop, recommend, and monitor corrective and preventive actions.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on QA Specialist jobs

Quality assurance specialists ensure production processes follow established regulations and quality standard.

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Quality assurance specialists need to outline quality assurance policies and procedures, making sure that quality standards are assured.

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Every QA team follows a process to have a bug tracking tool like Jira, bugzilla.

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Know how to ask the right questions, and when to ask them.

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Assure ongoing compliance with quality and industry regulatory requirements.

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Step 3: View the best colleges and universities for QA Specialist.

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